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Beckman Coulter UniCel DxC Synchron 600, Instructions For Use Manual

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Beckman Coulter UniCel DxC Synchron 600 Instructions For Use Manual Download Page 167

Calibration Acceptance Limits

 

Introduction

UniCel DxC Systems Instructions For Use   A13914

Reagent Load/Calibration

 

October 2005

Page 5-29

 5

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.  Calibration Acceptance provides a reference to the acceptable 
limits for calibration.

Viewing Calibrator Acceptance Limits

Follow the steps below to view calibration acceptance limits.

Step

Action

1

Select the Rgts/Cal icon from the menu bar.

2

Select Options [F6].

3

From the Cal Options dialog box, select Calibrator acceptance limits 
using the pull-down menu limits.

Chemistries appear with chemistry name, setpoint value(s), and 
appropriate limits.

4

Select <Next> or <Prev> to locate the calibrator of interest.

OR

Select the Calibrator Name options button <

▼

> at the top of the screen to 

view the List of Calibrators.

5

Select <Close> to exit the screen.

Summary of Contents for UniCel DxC Synchron 600

Page 1: ...ton CA 92835 U S A A13914 AB October 2005 UniCel DxC Synchron Clinical Systems Instructions For Use For In Vitro Diagnostic Use Only This manual is intended for UniCel DxC 600 UniCel DxC 800 Beckman Coulter Ireland Inc Mervue Business Park Mervue Galway Ireland 353 91 774068 REP EC ...

Page 2: ......

Page 3: ...4 Operation and Control Components 2 26 Main Operator Screen and Program Structure 2 27 Theory of Operation 2 37 Cartridge Chemistry Calibration Theory 2 38 Modular Chemistry Calibration Theory 2 49 Cartridge Chemistry Principles of Measurement 2 50 CHAPTER 3 Preparing Samples for Analysis 3 1 Routine Operation Overview 3 1 Sample Programming and Processing 3 2 How to Use Reserved Racks 3 8 CHAPTE...

Page 4: ... Control 4 45 CHAPTER 5 Reagent Load Calibration 5 1 Reagent Load 5 1 System Calibration 5 13 System Calibration Introduction 5 13 Loading a Calibrator Diskette 5 14 Calibrator Assignment 5 15 Calibration Status 5 16 Reagent and Calibration Status Warnings 5 17 Requesting a Calibration 5 18 Calibration Failure Messages 5 20 Within Lot Calibration 5 21 Enzyme Validator 5 25 Calibration Override 5 2...

Page 5: ...y Patient ID 8 5 Recalling Results by Run Date Time 8 6 Displaying Recalled Results 8 7 Critical Result Rerun Editing 8 8 Printing Recalled Results 8 10 Sending Results to the Host 8 11 Absorbance Versus Time 8 12 Statistical Summary Report 8 13 CHAPTER 9 User Defined Reagents 9 1 Overview 9 1 Requirements and Precautions 9 2 User Defined Reagent Setup 9 4 Chemistry Parameters 9 5 Processing Param...

Page 6: ... 10 Instrument Commands 11 11 Instrument Commands Summary 11 11 Home 11 12 Pause 11 13 Stop Print 11 15 Shutdown 11 16 System Power On Boot 11 19 Pause Resume Waste B 11 21 Enable Disable Modules 11 22 Unload All 11 24 CHAPTER 12 Utilities 12 1 Overview 12 1 Prime 12 2 Maintenance 12 7 Event Log 12 8 Alignment Diagnostics PVTs 12 14 Metering 12 15 Modem 12 16 Backup Restore 12 17 Touch Screen Cali...

Page 7: ... DxC Systems Instructions For Use A13914 Table of Contents October 2005 Page 5 of 6 Result Errors and Codes 13 18 Error Code Definitions 13 21 Common Error Messages and Corrective Actions 13 29 GLOSSARY INDEX ...

Page 8: ...Table of Contents UniCel DxC Systems Instructions For Use A13914 Page 6 of 6 October 2005 ...

Page 9: ...s are not discussed Refer to the reference materials below for detailed information Reference Manuals Other manuals that accompany the system include the UniCel DxC Synchron Clinical Systems Reference Manual which contains detailed system description comprehensive operating instructions theory of operation system calibration and programming procedures and quality control information for the UniCel...

Page 10: ...key in square brackets Example Select Print F10 Command buttons buttons with names on a screen or Buttons with names are bold and enclosed in angle brackets Example Select Cancel Instrument buttons Buttons on an instrument are in bold May be all upper case or initial caps Example Press the STOP button Keyboard keys Keyboard keys are written in bold and enclosed in square brackets Examples X or Tab...

Page 11: ...presented which describes the variable conditions in the left column and the appropriate action for each condition in the right column Example of Procedure Table The following table is an example of a procedure table that contains a decision table Read the decision table as a complete sentence using the first heading to introduce the condition and the second heading to introduce the action Step 2 ...

Page 12: ...pling CTS Cap Piercer Assembly Hazards Biohazards The Cap Piercer contains a razor sharp blade assembly that has been exposed to potentially biohazardous fluids The points of the Blade are very sharp and extend below the Wash Tower Stay away from the bottom of the Wash Tower To prevent injury or exposure do not touch the Points of the Blade and always wear gloves Do not select OK when the cover is...

Page 13: ...ior to servicing to avoid sudden depressurization and potential exposure of the skin or eyes to the No Foam solution To release the air pressure disconnect the white quick connector located at the supply side of the container If inhaled move exposed individual to fresh air If skin or eye contact with the solution occurs flush the affected area thoroughly with water for at least 15 minutes In both ...

Page 14: ...void skin contact with reagent Use water to wash reagent from skin Refer to the related Material Safety Data Sheets MSDS for additional information System Operations and Specifications Hazards System operation should be consistent with the power requirements as stated in the Summary of Hazards section of this chapter and should always conform to the procedures and safety warnings throughout this m...

Page 15: ...fer reagent is stable for one month on the system However if a color change from pink to a lighter shade of pink should occur replace the alkaline buffer with a fresh bottle of reagent Aqueous Calibrator Precautions Repetitive refrigeration of Synchron aqueous calibrators may facilitate crystal formation Once removed from refrigerated storage these calibrators should remain at room temperature The...

Page 16: ... BUNm UREAm Electrode Precautions Loosen the BUNm UREAm electrode retainer nut approximately one half turn and withdraw electrode slightly before removing the stir bar and 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 17: ...r flushing the Flow Cell Electrodes cleaning the EIC Ports bleaching CO2 Alkaline Buffer Reagent Straw and Line removing the CO2 Measuring Electrode Membrane replacing EIC Quad Ring Ratio Pump Quad Rings Alkaline Buffer Peri Pump Tubing or Sample and Reagent Syringes Environmental Conditions Precautions Changes in ambient temperatures and environmental conditions may result in a reference drift me...

Page 18: ... results will be obtained without proper amounts of reagents in the modules Therefore before starting any run verify that sufficient reagent is available to complete the run Modular chemistry reagent containers should not be handled while the system is performing modular chemistry measurements The use of expired reagents may cause erroneous results Residual Blood Contamination Precautions Before y...

Page 19: ...all quantity of carryover could greatly increase the results for example TBhCG If your system has a Closed Tube Sampling CTS option Do not run samples in cups on top of a sample tube This would give motion errors As an alternative put the sample in a nesting cup on a tube in a reserved rack System Backup Precautions After inserting a diskette into the floppy disk drive selecting OK when prompted w...

Page 20: ...the analyzer power is ON when this portion of the switch is in the down position Instrument Power Switch OFF This symbol also located on the main power switch indicates that the analyzer power is OFF when this side of the switch is in the down position Instrument or Printer Power Switch ON This symbol is located on the analyzer and printer power switch When the portion of the switch with this symb...

Page 21: ...round This symbol is used to indicate an electrical ground Keyboard Connection This symbol is found above the connection between the computer and the keyboard Can Hold This Object Here This black symbol located on the bottom of each sample and reagent probe assembly indicates that this area may be handled to rotate the probe Do Not Hold This Object Here This red symbol located on the top of each s...

Page 22: ...bol indicates a caution message and is followed by an explanation or other symbols that define the caution see examples below CAUTION Operate with All Covers in Place This symbol is located on top of the work surface cover and the cover of an optional Cap Piercer It indicates a caution to operate only with all covers in place to reduce risk of personal injury or biohazard General Biohazard These c...

Page 23: ...1mW CLASS II LASER PRODUCT is placed near any opening through which a bar code reading beam will emit Do not stare into laser light beam Laser A label reading AVOID EXPOSURE LASER LIGHT IS EMITTED FROM THIS APERTURE is placed near any opening through which a bar code reading beam emits Avoid exposure to laser light emitted Sharp Objects Caution A label reading CAUTION SHARP OBJECTS REFER SERVICING...

Page 24: ...l reading THIS DOOR SHOULD REMAIN CLOSED DURING SYSTEM OPERATION is found on the top edge of the left hand MC reagent door and indicates that the door should remain closed during system operation Read Manual Caution A label reading CAUTION READ MANUAL BEFORE OPERATING is found on the hydropneumatics behind the center door and recommends the operator read the manuals before operating the system A01...

Page 25: ...t into the autoloader Laser Certification Label This label is found on the back bottom edge of the system It provides information about the laser Ethernet Serial Port Label This label is found on the right side of the system and identifies connections for the Ethernet and serial ports A011540L EPS BECKMAN COULTER INC MADE IN U S A MARCA REG PRODUCT COMPLIES WITH 21 CFR CHAPTER I SUBCHAPTER J MANUF...

Page 26: ... on the European Market after August 13 2005 and 2 the device is not be disposed via the municipal waste collection system of any member state of the European Union 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 Beckm...

Page 27: ...ge 2 1 2 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: ...ns may affect the temperature control of the system Drain The system should be located near a sink or floor drain to accommodate the waste effluent at a minimum rate of 6 liters hour 16 liters hour continuous flow The drain must not be placed any higher than 36 inches 91 4 cm above the floor Table 2 1 Installation Requirements Item Requirement Installed by The DxC system is installed completely by...

Page 29: ... BTU hour at nominal estimated DxC 800 7 500 BTU hour at nominal estimated DxC PC 979 BTU hour Power connector 20 A current rating Nema L6 20R twistlock Uninterrupted power supply Refer to UPS manufacturer s literature for specifications NOTICE Line Voltage from the electrical outlet should be free of spikes fluctuations and dropouts for protection of the electronic circuitry CAUTION Only operate ...

Page 30: ...inimum 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 Table 2 6 IEC 1010 Specifications Item Specification Pollution Degree 2 EN55011 Meets Class A Maximum Sound Pressure 65 dBA average over 8 hours with covers down at 1 meter away from the inst...

Page 31: ... Chemistry Reagent Handling System Hydropneumatic System Operation and Control Components A Closed Tube Sampling System has optional components listed below Large Particle Immuno Assay Module LPIA Closed Tube Sampling CTS Figure 2 1 UniCel DxC 600 Analyzer Equivalent to Near Infrared Particle Immuno Assay NIPIA 1 Modular Chemistry MC Section 2 Cartridge Chemistry CC Portion 3 Autoloader 4 Reaction...

Page 32: ...System Components DxC Systems System Description UniCel DxC Systems Instructions For Use A13914 Page 2 6 October 2005 Figure 2 2 UniCel DxC 800 Analyzer A015901P EPS ...

Page 33: ...ples A detailed description of each component is presented in the following paragraphs Sample Racks A sample rack is a high strength plastic centrifugable holder designed to house up to four samples There are four sizes of racks with each size capable of holding one length width combination of primary sample tubes in addition to accepting sample cups Refer to Figure 2 3 Sample racks accept the fol...

Page 34: ...n in Figure 2 3 Figure 2 3 Rack 16 75 16 75 mm tubes 13 100 13 100 mm tubes 0 5 mL cups 2 0 mL cups Capillary collection tubes use with the capillary tube adapter Beckman Coulter Microtubes 16 100 16 100 mm tubes 16 92 mm tubes 16 5 100 mm tubes Beckman Coulter 0 5 mL Cup Insert P N 476399 Table 2 7 Sample Racks continued Rack Accepts These Cups and Tubes 2 of 2 1 Numeric Rack ID number 2 Rack siz...

Page 35: ... components allow for over one hour of uninterrupted sample processing with no operator intervention involved Figure 2 4 Sample Loading Area Priority Load Position Between the Autoloader and the Sample Gate is the Priority Load position This position is used in conjunction with the PRIORITY LOAD button when a rack is to be loaded onto the Sample Carousel into a reserved priority position so that i...

Page 36: ...ple Gate is the mechanism that moves racks from the load tray to the shuttle during the load process It also moves samples from the shuttle to the unload track during the unload process Refer to Figure 2 4 Shuttle The Shuttle moves the rack from the gate area onto the Sample Carousel Refer to Figure 2 4 Bar Code Reader Sample The Bar Code Reader is a Class II fixed beam laser scanner It is used to...

Page 37: ...o CTS Both open and closed tubes can be in the same sample tube rack Refer to Symbols and Labels in CHAPTER 1 General Information for a description of the CAUTION labels for the Cap Piercer 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 Table 2 8 Tubes Validated for Closed Tube Sa...

Page 38: ...k 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 Figure 2 5 Sample Carousel Area 1 Liquid level sense assembly 2 Sample probe CC 3 Collar wash 4 Sample Carousel A015903P EPS 1 2 3 4 ...

Page 39: ...Electrolyte injection cup EIC Flow cell assembly Chemistry reaction modules A detailed description of each component is presented in the following paragraphs Reagent Storage Area The reagent containers used to supply the modular chemistries are located behind the left front door of the system The only exception is the CO2 alkaline buffer which is located on the ISE module Figure 2 6 Modular Chemis...

Page 40: ...and the trigger is pressed the identity of the reagent the lot number and reagent volume are automatically entered into the reagent load screen Ratio Pump The Ratio Pump is a motor driven multicylinder positive displacement pump used to deliver the necessary reagents to the ISE flow cell Refer to Figure 2 7 It consists of a three step piston housed in three stacked independent cylinders Figure 2 7...

Page 41: ...e A13914 System Description October 2005 Page 2 15 2 Electrolyte Injection Cup EIC The EIC mixes the sample and buffer prior to delivery of the sample now diluted to the flow cell Figure 2 8 Electrolyte Injection Cup 1 Waste outlet 2 Flow Cell outlet 3 Buffer inlet 4 Reference inlet 5 DI H2O inlet ...

Page 42: ...l assembly houses the seven electrodes that perform the analysis of sodium potassium chloride carbon dioxide and calcium Refer to Figure 2 9 Figure 2 9 Flow Cell 1 Inlet port 2 CL electrode 3 K electrode 4 CO2 reference electrode 5 CO2 electrode 6 Exit port for waste large tube 7 Exit port for internal reference 8 Na reference electrode 9 Na electrode 10 Ca electrode ...

Page 43: ...istry 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 Figure 2 10 Basic Components of Modules Ex Albumin 1 Circuit board behind protective shield 2 Reaction cup 3 Reaction cup housing 4 Mixer motor assembly 5 Reagent pump ass...

Page 44: ...robe assembly Reagent mixer assembly Mixer wash cup The Reagent Handling system is used to transfer reagent from the individual cartridges to the reaction cuvettes for processing and analysis of the requested chemistry tests Reagent Cartridges Reagent cartridges are single use recyclable plastic containers that house the individual liquid reagent components necessary to perform a chemistry test Th...

Page 45: ...ture of 5 C 3 C Figure 2 12 CC Dual Carousels with Two Bar Code Readers Reagent Bar Code Reader CC The Bar Code Reader refer to Figure 2 12 situated near the front of the Cartridge Chemistry reagent access door scans each label during the loading of reagent cartridges Only the reader for the selected carousel is active An audible signal acknowledges successful reading of the label The Reagent Prob...

Page 46: ...r Assembly This assembly consists of a mechanical structure that supports a single moveable crane Attached to the crane is a high speed mixer Refer to Figure 2 13 Reagent Mixer Wash Cup The Mixer Wash Cup sprays the mixer with diluted wash solution while the mixer moves up and down in the cup Refer to Figure 2 13 1 Reagent Mixer 2 CC Reagent Probe A 3 CC Reagent Probe B 4 Collar Wash A015908P EPS ...

Page 47: ...of obtaining absorbance readings from each cuvette during the analysis cycle Following the completion of each chemistry test the cuvettes are processed through a wash station in preparation for the next chemistry A description of each component is presented in the following paragraphs Reaction Carousel The reaction carousel assembly refer to Figure 2 14 supports a total of 125 cuvettes Each cuvett...

Page 48: ...tics station during a spin cycle the xenon lamp is flashed and the resulting light beam travels through the opposing sides of the square cuvette LPIA Large Particle Immuno Assay or NIPIA Near Infrared Particle Immuno Assay Module optional The optional LPIA module uses a photometric detection system for large particle immuno assays This assembly is attached to the reaction carousel support frame to...

Page 49: ...te 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 Figure 2 15 Cuvette Wash Station 1 Probe 1 2 Probe 2 3 Probe 3 4 Probe 4 5 Wash station ...

Page 50: ...ocks 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 Figure 2 16 DxC 800 Hydropneumatics right side Function The function of the hydropneumatic system is to provide the following media to the different functional areas of the instrument Vacuum Compressed air Diluted wash solution Deionized water 1 Wash concentr...

Page 51: ...s For Use A13914 System Description October 2005 Page 2 25 2 Figure 2 17 DxC 800 Hydropneumatics left side 1 Waste exit 2 Waste B exit 3 DI water inlet On Off 4 DI water reservoir 5 Vacuum accumulator 6 Waste B canister 7 Waste canister A015911P EPS 2 3 4 5 6 7 1 ...

Page 52: ... Push button controls refer to Figure 2 4 are used to start the process to prioritize a sample run or to stop the process under certain conditions as described in Table 2 9 below Table 2 9 DxC Push Button Controls Push Button Control Type Primary Function Run To start the test process Priority To prioritize the loading of a rack by creating a space in front of the autoloader for loading the next r...

Page 53: ...ault is English To reach the on line Help system select the Question Mark icon on the right side of the Function Selection Icon menu The system will offer three options Install an On Line Instructions For Use manual IFU View the installed On Line Instructions For Use manual View the License Agreement When you access the On Line Instructions For Use manual screen the currently loaded language manua...

Page 54: ...er to item 1 on Figure 2 18 appears in the blue bar at the top left side of the Operator screens when the Closed Tube Sampling CTS option is installed When CTS appears Closed Tube Sampling is enabled When CTS appears within the international No symbol the feature is not enabled When the indicator is absent the CTS option is not installed Enabling and disabling Closed Tube Sampling is accomplished ...

Page 55: ...creens refer to item 3 on Figure 2 18 It shows the current state of the system either Running or Standby When both the Modular Chemistry MC and the Cartridge Chemistry CC functions have the same status a single status indicator appears When the statuses of these components are different the MC Status is shown on the left and the CC Status appears on the right For example Running Standby would indi...

Page 56: ...un F10 Post Run Samples Main F1 Sample F2 Edit F3 Urine F10 Next Clear OK Smp ID Only F3 Options F5 Control F6 Remove F8 Rgt Cart F9 Cancel F10 Save Select All Batch Cancel Sample IDs Rack s Position s Date Time From To OK Cancel F1 Clear F9 Cancel F10 Program Sample ID s From To Rack s Position s Date Time From To Status Print Display Cancel Plot Table Both Print Next Prev Done Sample Required In...

Page 57: ...mits Modify set points Slope Offset adjustment Within lot calibration Enzyme Validator Calibration override Bypass chemistry Extend calibration time Print cal report Cancel Avail Racks Next Prev Close Position Chemistry Tests Left Days Left Cal Time Left OK F2 Control ID F3 Delete F9 Print F10 Done F1 Chems F2 Control ID F3 Delete F10 Done F1 All Chem F2 All File F10 Done QC Date Range OK Cancel F...

Page 58: ...ore F10 Done F1 Restore F10 Done F1 Define F2 Delete F3 Default F10 Done MC STAT Host Printer MC ALL Host Printer Immediate Report of Reruns OK Cancel Report Header Patient Format Control Format Inter Laboratory Information Print Patient and Control Report F1 Restore F10 Done Define Edit Cancel Define Edit Clear Ranges 10 Reference Critical Ranges 11 Sample Comments F1 Chems F2 UDR F3 Define F4 Cl...

Page 59: ... Done F1 Define F2 Delete F4 Config F9 Print F10 Done Code 39 Parameters Codabar Parameters Interleaved 2 of 5 Parameters Code 128 Barcode Mode Rack Position Mode Maximum Sample Program Age Days Hours F10 Done 1 Blade Thick CTS Reserved Racks 75mm Racks 100mm Racks Obstruction Detection Reserved Racks for HbA1c Reserved Racks for IBCT Restore Defaults OK Cancel F1 Restore F2 Diag F10 Done Language...

Page 60: ... Log F10 Exit All CC Subsystems 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 Cuvette Wash Fill Canisters and reservoirs CC Drain waste sump CC Drain waste B sump Drain gravity drain sump Cup Selection ALBm DxC 800 only CREm DxC 800 only GLUCm DxC 600 only PHOSm DxC 800 onl...

Page 61: ...ystem Hydropneumatic System ISE Module System Modular Cup Chemistry Module Valve and Fluidics Align All Reaction Carousel Cuvette Wash Station Reagent Carousel Sample Carousel Sample Rack Handling Sample Rack Barcode Reader Cap Piercer CC Sample Crane or Probe CC Sample Crane Smart Module B2 MC Sample Crane or Probe MC Sample Crane Smart Module 52 Reagent A Crane or Probe Reagent A Crane Smart Mod...

Page 62: ...ional Area Selected F10 Exit 7 Modem 8 Backup Restore 9 Metering 10 Touch Screen Calibration F1 Summary F2 Count F3 Temp F4 Power F5 Hydro F6 Smrt Mdl F7 Cuv Stat F8 CTS F10 Print 1 Home 2 Pause 3 Stop Print 4 Shutdown 5 Pause Waste B 6 Resume Waste B 7 Enable Disable Modules 8 Unload All System Parameters Alignment Data Files Backup Restore Cancel F1 Disk F2 Replen F3 Report F4 Off F5 Modem F9 Ca...

Page 63: ...cessing 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 These analyses are referred to as cartridge chemistries because the reagents are stored in cartridges Cartridge Chemistry CC Sample and Reagent Processing During operation a number of events occur ...

Page 64: ...mistries Calibration of endpoint and first order rate chemistries involve the use of a single level calibrator solution or a two level calibrator kit Each analyte in the calibrator solution has a known concentration value associated with it With each new lot of calibrator solution the values are transferred from disk and stored in memory for later use in the calibration procedure For most calibrat...

Page 65: ...dpoint and Rate Chemistries Type Formula Nonblanked Endpoint Chemistries FOR HIGH CALIBRATOR LEVEL Reaction ABS ABSrep1 Reaction ABS ABSrep2 ABSrep1 ABSrep2 0 5 ABSavg hi FOR LOW CALIBRATOR LEVEL Reaction ABS ABSrep1 Reaction ABS ABSrep2 ABSrep1 ABSrep2 0 5 ABSavg lo Offset Cal Set Point hi Cal Factor ABSavg hi Sample values are calculated by the following equation Reaction ABS Cal Factor offset s...

Page 66: ...Blank ABS Delta ABSrep1 Reaction ABS Blank ABS Delta ABSrep2 Delta ABSrep1 Delta ABSrep2 0 5 Delta ABSavg lo Offset Cal Set Point hi Cal Factor Delta ABSavg hi Sample values are calculated by the following equation Reaction ABS Blank ABS Cal Factor offset sample value NOTICE For single point linear calibration the low calibrator is a fixed zero point and the offset is equal to zero Table 2 12 Calc...

Page 67: ...ion Factor Delta ABSrep2 Delta ABSrep1 Delta ABSrep2 0 5 Delta ABSavg lo Offset Cal Set Point hi Cal Factor Delta ABSavg hi Sample values are calculated by the following equation Reaction ABS Blank ABS Blank Correction Factor Cal Factor offset sample value NOTICE For single point linear calibration the low calibrator is a fixed zero point and the offset is equal to zero Table 2 12 Calculation of C...

Page 68: ...action Rate Raterep1 Reaction Rate Rate rep2 Raterep1 Raterep2 0 5 Rateavg lo Offset Cal Set Point hi Cal Factor Rateavg hi Sample values are calculated by the following equation Reaction Rate Cal Factor offset sample value NOTICE For single point linear calibration the low calibrator is a fixed zero point and the offset is equal to zero Table 2 12 Calculation of Calibration Factors for Endpoint a...

Page 69: ...ank Rate Delta Raterep1 Reaction Rate Blank Rate Delta Raterep2 Delta Raterep1 Delta Raterep2 0 5 Delta Rateavg lo Offset Cal Set Point hi Cal Factor Delta Rateavg hi Sample values are calculated by the following equation Reaction Rate Blank Rate Cal Factor offset sample value NOTICE For single point linear calibration the low calibrator is a fixed zero point and the offset is equal to zero Table ...

Page 70: ...ion Factor Delta Raterep2 Delta Raterep1 Delta Raterep2 0 5 Delta Rateavg lo Offset Cal Set Point hi Cal Factor Delta Rateavg hi Sample values are calculated by the following equation Reaction Rate Blank Rate Blank Correction Factor Cal Factor offset sample value NOTICE For single point linear calibration the low calibrator is a fixed zero point and the offset is equal to zero Table 2 12 Calculati...

Page 71: ...includes the sample diluent DIL1 used as a blank that is subtracted from all calibrator or sample responses Multi point chemistry calibration consists of five or six different levels of calibrators These chemistries set calibration based on single replicates of each calibrator level Single point chemistry calibration consists of one or two levels of calibrators These chemistries set calibration ba...

Page 72: ... cannot be solved directly for concentration The instrument uses an iterative method to determine the sample value Model 3 Math Model 3 is a five parameter exponential function This function cannot be solved directly for concentration The instrument uses an iterative method to determine the sample value Models 4 through 7 These Models are reserved for future development Model 8 Math Model 8 is an ...

Page 73: ...rate of the low cutoff calibrator and reported out as POSITIVE or NEGATIVE Cutoff values are stored in memory until the next successful calibration Model 9 Math Model 9 is an extension to model 1 the four parameter log logit function The c is allowed to be either 1 or 1 If c 1 then this is equivalent to model 1 If c 1 an alternative function is being used This function cannot be solved directly fo...

Page 74: ...nzyme 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 re...

Page 75: ...The resulting ADC values are compared to pre programmed back to back span and range limits to determine the calibration acceptability Modular Chemistries MC The UniCel DxC contains seven chemistry modules see chart below each of which is used in the determination of eleven modular chemistries MC as follows Table 2 14 Methodology and Modules Used with Modular Chemistries Chemistry Methodology Modul...

Page 76: ...or more appropriate chemical reagents produces a substance that has the ability to absorb light at specific wavelengths This substance is referred to as a chromophore Beer s Law According to Beer s Law the amount of light absorbed by the chromophore is proportional to the concentration of the constituent being measured The system can measure this as an endpoint or a rate of formation A abc where A...

Page 77: ... completed Step Action 1 If necessary start the system 2 Check reagent status Load reagent as necessary 3 Check calibration Program or load calibrators as needed 4 Program or load controls if required 5 If the system is not already running press the RUN button on the system 6 Check the control results to verify system operation 7 Program or load patient samples 8 If the system has gone into Standb...

Page 78: ... of individual tests Samples may be described and defined through sample type sample comment patient ID and patient demographic functions A sample can be programmed as a control sample or as a STAT for priority processing Once programmed samples are placed on the autoloader for processing Program Samples and Controls Refer to this chapter for Sample information and CHAPTER 6 Quality Control for Co...

Page 79: ...the following tube and cup sizes Table 3 1 Sample Racks Rack Accepts these cups and tubes 13 75 12 75 mm tubes 13 75 mm tubes 0 5 mL cups 2 0 mL cups 16 75 16 75 mm tubes 13 100 13 100 mm tubes 0 5 mL cups 2 0 mL cups Capillary collection tubes use with the capillary tube adapter 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 ad...

Page 80: ...orage Beckman Coulter Synchron Microtube Pipette the sample into a Synchron Microtube Verify there are no bubbles at the bottom of the tube Place into a 13 100 reserved rack Autoanalyzer Cup Place the cup into a rack OR Place in 15 85 tube with sample bar code on tube Verify there are no bubbles in sample If cup is placed in a tube with a Bar Coded label a reserved rack must be used BD Microtainer...

Page 81: ...mple tubes If a CTS assembly is installed the operator can enable disable the CTS assembly A CTS Tracking database monitors pierced tubes If you run a tube again it will not be pierced again The sample ID stays in this database for seven days for a tube that has been pierced Table 3 3 Tubes Validated for Closed Tube Sampling CTS Configuration Tubes Validated for Cap Piercing Size 1 Blade Thick CTS...

Page 82: ...le containers in this rack will not be cap pierced even if the Cap Piercing feature is enabled Level sensing on samples in the rack will be set to its most sensitive level to detect small sample volumes This type of reserved rack may be used for uncapped primary or secondary tubes that have a small volume of sample for example nested cups on primary tubes Microtubes and pediatric capillary collect...

Page 83: ...group requires some sort of sample preparation If these tests are part of a group of other tests that do not require preparation they cannot be run at the same time as the others Using these features allows the prepared sample to be run in one of the reserved racks and allows the result of the prepared sample to be merged with the original sample report when all tests are complete The default for ...

Page 84: ...OT run a closed tube in a reserved rack 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 0 5 mL Cup Insert P N 476399 Brown Racks Series 451 499 to run IBCT Blue Racks 0 5 mL Cup Insert P N 476399 NOTICE T...

Page 85: ...menu bar 2 Select the Page Down button on the right side of the screen 3 Select 17 Reserved Racks Obstruction Detection OR Type 17 in the Option Number field and press Enter The following screen appears Figure 3 1 4 Type the rack numbers to assign as reserved racks in the HbA1c and IBCT fields AND OR Type the rack numbers to assign as reserved racks 5 Select OK to assign the racks OR Select Cancel...

Page 86: ...cal Systems Reference Manual Bar Code Label Placement Bar code labels must be applied to each sample tube in the correct location so that the bar code reader can read the bar code The following diagram Figure 3 2 describes how to place the label on a sample tube and how to place the tube into a sample rack Figure 3 2 Bar Code Label Placement CAUTION A misread label can cause one sample ID to be re...

Page 87: ...the rack bar code label 2 For closed tube sampling systems check the top of the validated closed tube for visible blood If blood is present clean the rubber stopper with a cotton tipped applicator stick For non CTS Systems or tubes not validated for closed tube sampling remove the cap 3 For a Routine Sample or if system is in Standby Priority samples should be placed on the autoloader first Place ...

Page 88: ...sample is identified by a Sample ID and or rack and position The user selects tests for programming The following items require manual programming samples without bar codes samples with bar codes and no sample programming If Then Individual Samples Select the Samples icon from the menu bar Type rack and position Type Sample ID Save F10 Several samples in the same rack Select the Samples icon from ...

Page 89: ...s select Demog F2 Type in the information provided and select Next F10 to return to the Program Sample screen 8 Select each chemistry and or select a panel To access additional chemistries use the up and down arrows to move to other pages 9 Select Next F10 10 To program additional samples repeat Steps 2 8 11 Get the rack s listed on the screen and place the samples into assigned rack positions as ...

Page 90: ...or rack and position for rerun One or more samples can be programmed to rerun 4 Select one of the following buttons To add or rerun specific tests press the Select button All previous programming will be highlighted Deselect chemistries that are not to be run To rerun all completed tests press the All button Rerun all completed tests for all requested samples Go to Step 6 5 Select Next F10 6 For a...

Page 91: ...e field For example range 1 thru 1000 would not include sample 0099 but range 0001 thru 1000 would Sample IDs containing only Alpha or Alphanumeric Data Samples are listed in dictionary order For example A AB B Numbers come before letters For example 1 900 1A A Include all characters in the To field For example range A thru Z would not include ZEBRA but range A thru ZZZZZZZZZZZZZZ would If Then Sa...

Page 92: ...ple ID does clear rack position in which the Sample ID was located Deletion Criteria Procedure for Sample Clearing Sample ID Type in the Sample ID s to be cleared Single and multiple IDs may be cleared Use a comma to separate a list of IDs Range of Sample IDs Refer to Range of Sample IDs in this chapter for additional information Type the first Sample ID in the Range field Type the last Sample ID ...

Page 93: ... Page 4 1 4 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 and Figure 4 2 below Figure 4 1 Setup Screen scrolled to the top Figure 4 2 Setup Screen scrolled to the bottom E015930S EPS E015931S EPS ...

Page 94: ...stem Setup Options UniCel DxC Systems Instructions For Use A13914 Page 4 2 October 2005 For detailed step by step instructions on using the System Setup option refer to the UniCel DxC Synchron Clinical Systems Reference Manual ...

Page 95: ...owing features may be password secured Results Edit Rgts Cal Modify Set Points Rgts Cal Slope Offset Adjustment Rgts Cal Within Lot Calibration Rgts Cal Enzyme Validator QC Setup Utils Clear Event Log Defining Editing Password Setup To define edit or delete user names passwords privilege levels and accessibility levels follow the steps below Step Action 1 Select the Setup icon from the menu bar 2 ...

Page 96: ...ed Select New F1 to enter the password setup for a new user OR To edit the password setup for a user select the user s password number OR Type the user s password number in the Numbers field and press Enter Select Define F2 5 In the Define Edit Password dialog box type the information requested NOTICE Do NOT type beckman in the Password field Select Administrator in the Title field to allow the us...

Page 97: ...function in Sample Programming is used for samples which are known to exceed the usable range Chemistries designated with manual ORDAC at the time of programming are run at the ORDAC sample volume From the Setup Screen select 1 Auto Serum Index ORDAC to enable or disable ORDAC The default for Auto ORDAC is OFF The Automatic ORDAC screen may be viewed at any time however the system must be in Stand...

Page 98: ...nted with the test results for a control sample Auto Serum Index is intended for sample integrity assessment only not for patient diagnosis For additional information on Serum Indexing refer to the Synchron Clinical Systems Chemistry Information Manual From the Setup screen select 1 Auto Serum Index ORDAC to enable disable Auto Serum Index To enable or disable Auto Serum Index the system must be i...

Page 99: ... 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 Select the DxC chemistry from the pop up list Configuring a User Defined Chemistry UDR The chemistry menu available in sample programming quality control panel definition and other...

Page 100: ...vent problems with deleting chemistries from the QC definition 1 Remove the chemistry from Reagent Calibration Example DIG NOTICE Control samples in the sample required incomplete or rerun status may prevent the removal of the chemistry from the QC definition Step Action 1 Select the Rgts Cal icon from the menu bar 2 Ensure the cal status of the chemistry DIG is not Requested To cancel a calibrati...

Page 101: ...uld be allowed to proceed to complete or incomplete status Step Action 1 Request sample load lists for a Sample Required b Incomplete and c Rerun 2 Select the Samples icon from the menu bar 3 Select List F9 4 Select the options button next to the Status field at the bottom of the Load List dialog box to view the List of Sample Status 5 Select Sample Required for a list of samples 6 Select Display ...

Page 102: ...C files for the control will be deleted Archiving is suggested Delete this control Select OK to delete the control 5 If the control was deleted type in an operator ID of from 1 3 alphanumeric characters and press the Enter or Tab key Step Action 1 Select the QC icon from the menu bar 2 From the QC screen select a control number 3 Select Define F2 4 Select Chems F1 A list of configured chemistries ...

Page 103: ...HAPTER 3 Preparing Samples for Analysis Clearing Samples If not patient samples are purged during rollover at 10 000 Patient IDs or 150 000 results whichever comes first Table 4 1 UniCel DxC 600 800 Beckman Coulter Defined Chemistries with Acronyms Units and Precision Beckman Coulter Defined Chemistry Acronym Units Precision Acetaminophen ACTM µg mL X X Alanine Aminotransferase ALT IU L X Alanine ...

Page 104: ... C Reactive Protein CRP mg dL X X C Reactive Protein C RP mg dL X XX C Reactive Protein High Sensitivity CRPH mg dL X XXX Creatine Kinase CK IU L X Creatine Kinase N acetyl L Cysteine CK IU L X Creatine Kinase MB CKMB U L X X Creatinine CREA mg dL X X Creatinine CSF CREm mg dL X XX Creatinine Serum Plasma Urine CREm mg dL X X Direct Bilirubin DBIL mg dL X X Digoxin Immuno Turbidimetric DIGN ng mL ...

Page 105: ...thaqualone METQ mA min X XX Microalbumin MA mg dL X XXX Microprotein M TP mg dL X Opiate 2000 ng mL cutoff OP2 mA min X XX Opiate 300 ng mL cutoff OP mA min X XX Pancreatic Amylase PAM U L X Phencyclidine PCP mA min X Phenobarbitol PHE µg mL X X Phenytoin PHY µg mL X X Phosphorus modular PHOSm mg dL X X Phosphorus Serum Plasma Urine PHS mg dL X X Potassium K mmol L X X Prealbumin PAB mg dL X XX Pr...

Page 106: ...lar Serum Plasma TPm g dL X X Total Protein Serum Plasma TP g dL X X Transferrin TRFN mg dL X X Triglycerides GPO TG mg dL X Triglycerides GPO Blanked TG B mg dL X Urea UREA mmol L X X Urea modular UREAm mmol L X X Urea Nitrogen BUN mg dL X Urea Nitrogen modular BUNm mg dL X Uric Acid URIC mg dL X X Valproic Acid VPA µg mL X X Vancomycin VANC µg mL X X Table 4 1 UniCel DxC 600 800 Beckman Coulter ...

Page 107: ...roduction 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 Chemistry Configuration Sample Type from the Setup screen Select the Default Sample Type pull down menu at the top of the screen ...

Page 108: ...t any time but may only be modified when the system status is Standby or Stopped Setup To access Date Time setup from the Setup screen select 3 Date Time Then press Date F1 or Time F2 respectively to change the date and or time formats for the system Or you can press the Restore F3 key to restore the default display format The default Date Display Formats are Order mm dd yy Day Format Leading Zero...

Page 109: ...on 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 To change demographic field settings the system must be in Standby or Stopped The system default is ALL demographics fields shown ...

Page 110: ...lity to enable or disable the report at both the printer and at the host Output may be generated to 1 the printer 2 the host 3 both printer and host or 4 neither printer nor host Immediate reporting to the host can also be enabled for Critical Result Reruns Chemistries which are not complete at the time of interim STAT or ALL reports are designated by the message Results Not Available in place of ...

Page 111: ...he Panel Summary screen then select F1 to define edit or F2 to delete panels Panel definitions may be viewed and modified at any time Selecting a Default Panel The operator may select one of the defined panels as the Default Panel The DxC system selects the Default Panel as the test s to run when the sample ID has no programming assigned or after a Host Query time out From the Setup screen select ...

Page 112: ...replicates per sample may also be edited by accessing a specific sample program A maximum of 20 replicates may be assayed from a sample All results are printed and maintained in memory for recall Setup From the Setup screen select 7 Replicates to define the number of replicates or restore the system Default Replicates value The Replicates option may be viewed at any time The system must be in Stan...

Page 113: ...ct from a variety of Control Report formats Define Inter Laboratory information to print in a report Setup From the Setup screen select 8 Report Setup to make selections or changes to report setup specifications Report Setup may be viewed at any time The Report Print option enable disable may be changed at any time The system must be in Standby to edit Patient or Control Report formats or the Inte...

Page 114: ...Instrument Printable Range is suppressed Reportable Range The Reportable Range is operator defined and represents the range verified at the operator s site The Reportable Range may or may not be the same as the Analytical Range A result exceeding the Reportable Range is flagged ORR HI or ORR LO Out of Reportable Range The Reportable Range features is available on all configured chemistries except ...

Page 115: ... Options October 2005 Page 4 23 4 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: ...anges based on its own population demographics The Critical Range limits are used in conjunction with the Critical Results Rerun option When the limits of the critical range defined by the operator are exceeded the system will automatically rerun the analyte The operator may delete one result or send both to the host The Critical Result Rerun option should not be enabled for analytes with POS or N...

Page 117: ...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 Up to 25 alphanumeric characters including spaces and punctuation are allowed Sample Comments may be modified at any time ...

Page 118: ...iate chemistries for the equation are programmed and run for a given sample ID From the Setup screen select 12 Special Calculation to define edit delete or view a special calculation Special Calculations may be viewed at any time 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 ...

Page 119: ...4 2 Beckman Coulter Predefined Special Calculations Defaults continued Calculation Unit Precision Sample Type 2 of 2 Table 4 3 UniCel DxC 600 Predefined Special Calculation Formulas Calculation Formula Osmality 1 1 86 NA GLUCm 18 BUN 2 8 9 Osmality 2 1 86 NA GLUCm 18 UREA 9 Anion Gap 1 NA CL CO2 Anion Gap 2 NA K CL CO2 A G Ratio ALB TP ALB Indirect Bili TBIL DBIL BUN Crea Ratio BUN CREA Urea Crea ...

Page 120: ...ormulas Calculation Formula Osmality 1 1 86 NA GLUCm 18 BUNm 2 8 9 Osmality 2 1 86 NA GLUCm 18 UREAm 9 Anion Gap 1 NA CL CO2 Anion Gap 2 NA K CL CO2 A G Ratio ALBm TPm ALBm Indirect Bili TBIL DBIL BUN Crea Ratio BUNm CREm Urea Crea Ratio UREAm CREm 0 0884 Free Thyroxine T4 TU 0 342 Crea Clearance 1 U V P 1 73 A reported in mL min Crea Clearance 2 U V P 1 73 A reported in mL sec ApoA ApoB ApoA ApoB...

Page 121: ... 600 800 performs additional calculations to accurately report the concentration as a function of volume and time Calculation Constants and Factors The sample volume is always expressed in milliliters mL The selectable units for any given chemistry are always expressed as weight per milliliter therapeutic drugs only and this would be extremely rare deciliters or liters Therefore the factors applie...

Page 122: ...13914 Page 4 30 October 2005 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 ...

Page 123: ...atures affected by the change such as reference ranges and calibration values will automatically convert to match the new units Units cannot be changed for chemistries that are defined for a control in QC Setup From the Setup screen select 14 Units Precision to modify units and number of decimal places or to restore defaults The Unit Selection Precision may be viewed at any time The system must be...

Page 124: ...October 2005 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: ...rameters Restore defaults The four sample bar code types that may be used on the DxC are Code 39 Codabar Interleaved 2 of 5 Code 128 Any combination of bar code types may be enabled Setup From the Setup screen select 16 Bar Code to enable disable bar code types to further define bar code parameters or to restore defaults Bar Code Setup may be viewed at any time The system must be in Standby or Sto...

Page 126: ...wed 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 This feature is useful when Sample IDs are reused regularly Setup From the Setup screen select 16 Barcode and check the box beside Maximum Sample Program Age to enable this feature The operator may enter the time limit in hours or days T...

Page 127: ...f HbA1c or IBCT samples For a CTS system assign rack numbers to the proper rack size Restore defaults Setup From the Setup screen scroll down and select 17 Reserved Racks Obstruction Detection to enable disable CTS enable disable obstruction detection assign reserved rack numbers for small sample volume containers HbA1c or IBCT or to restore defaults The system must be in Standby or Stopped to mak...

Page 128: ...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 Setup The system must be in Standby or Stopped to change this option From the Setup screen scroll down and select 18 Disable Service Monitor The default is Disabled ...

Page 129: ...ntation for the host parameters Table 4 5 Host Communications Parameter Table Parameter Options Default Device ID 0 99 0 Flow Control Software XON XOFF Hardware RTS CTS No Flow Software XON XOFF Data Transmission Mode Transmission OFF Unidirectional Bidirectional Bidirectional with Query Unidirectional Interface CX7 Compatible LX20 DxC CX7 Compatible Data Bits 8 7 8 Stop Bits 1 2 1 Parity None Odd...

Page 130: ...lowing 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 Changing from Japanese to any other language or keyboard will require a reloading of the operating software The system must be in Standby or Stopped to make modification...

Page 131: ...2005 Page 4 39 4 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 S Domestic 8 11 inches ...

Page 132: ...able to access the protected features in this area and in the way tests are counted if on a metered reagent plan there is no difference in system operation while in this mode While using the Service Setup feature the menu bar is green 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 p...

Page 133: ...s feature allows changes to be made to both areas If changes are necessary the new information will be supplied by 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 ...

Page 134: ...r 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 Never turn off power to the system or console while loading software Please refer to the UniCel DxC Software Installation Procedure shipped with the CD ROM ...

Page 135: ... 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 The system default is NO ALARM Changes to the alarm may be made at any time Although the system will continue providing pop up notes requiring operator attention disabling the al...

Page 136: ...istries 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 The system must be in Standby or Stopped state to load new software Never turn off power to the system or console while loading software Please refer to the UniCel DxC Software Installation Procedure shipped with the CD ROM NOTICE ...

Page 137: ...eration of Control is enabled the automatic Multiple Cartridge option is available With the Multiple Cartridge option enabled the system will automatically run all cartridges on board and runnable for any chemistries for an Auto Generated control Enabling Multiple Cartridge without Auto Generation will have no effect on the manual programming of control samples Setup From the Setup screen scroll d...

Page 138: ...Auto Generation of Control Setup System Setup Options UniCel DxC Systems Instructions For Use A13914 Page 4 46 October 2005 ...

Page 139: ...reagents are stored inside the lower left compartment in either 500 mL 1 L or 2 L bottles Other solutions associated with modular reagents include No Foam used with CREA chemistries CTS Auto Gloss used to lubricate CTS blade Wash Concentrate Buffer II Alkaline Buffer No Foam CTS Auto Gloss and Wash Concentrate II are stored in bottles in the center Hydropneumatics compartment The Alkaline Buffer i...

Page 140: ... of the instrument and can be made while the system status is in Standby or Running The system automatically senses the level of reagent in all the cartridges Reagent status messages are listed in Table 5 1 Table 5 1 Reagent Status Messages Message Explanation Load Requested Reagent position has been requested for reagent load but the system is running Parameters Required Parameters for a reagent ...

Page 141: ...ments n a Reagent status is not applicable for a chemistry e g an electrolyte chemistry Table 5 1 Reagent Status Messages continued Message Explanation 2 of 2 Step Action 1 Select the Rgts Cal icon from the menu bar 2 Select Sort F9 A dialog box appears 3 Select the sorting option in which the CC Chems should be shown Position on reagent carousel Chemistry Lists CC Chems alphabetically The oldest ...

Page 142: ...ar 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 Modular Chemistry MC Reagents The Modular Chemistries MC reagents are stored in either 500 mL 1 L or 2 L bottles Refer to Figure 5 3 Figure 5 4 and Figure 5 5 1 Reagent Name 2 Serial Number 3 Lot Number 4 Expiration D...

Page 143: ...005 Page 5 5 5 Figure 5 3 DxC 800 Leftmost Compartment Figure 5 4 DxC 600 Leftmost Compartment 1 BUNm UREAm 2 PHOSm 3 GLUCm 4 TPm 5 ALBm 6 CREm 7 Electrolyte Buffer 8 Electrolyte Reference 9 CO2 Acid 1 GLUCm 2 CO2 Acid 3 Electrolyte Buffer 4 Electrolyte Reference A015920P EPS 1 2 3 4 5 6 7 8 9 A015921P EPS 2 4 1 3 ...

Page 144: ...by the system after the initial volume is set When a new reagent bottle is replaced the system assumes the bottle is 100 full If the new bottle is not 100 full the volume may be adjusted Load Unload Modular Chemistries MC 1 Wash Concentrate II 2 No Foam solution 3 CTS Auto Gloss Step Action 1 Select the Rgts Cal icon from the menu bar 2 Select the Modular Chemistries MC Rgts 3 Select Load F1 4 Ope...

Page 145: ...tle of No Foam solution into the empty container on the instrument Refer to Figure 5 6 below and refill the No Foam container as follows Wipe off dust around top of lid 1 Vent the No Foam container 2 by disconnecting the white connector 3 at supply side of container Unscrew cap 4 from top of lid 1 Using the hand held bar code reader scan the bar code on new No Foam bottle Pour bottle contents into...

Page 146: ...before loading Check cartridges for bubbles in the reagent compartments before loading Use an applicator stick to remove bubbles 6 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 info...

Page 147: ...on Load Unload Cartridge Chemistries CC 1 Reagent Name 2 Lot Number 3 Expiration Date 4 Serial Number Step Action 1 Select the Rgts Cal icon from the menu bar 2 Select all positions to be loaded or unloaded Selected positions will be highlighted Use the up and down arrows to access screens for additional chemistries 3 Select Load F1 1 of 2 A016485P EPS 1 3 4 2 ...

Page 148: ...e bar code reader a beep will indicate that the bar code is read Check the screen to verify reagent data is removed from the position selected If the bar code does not read manually clear the position To manually clear select the Chem to be removed and select Clear F1 Figure 5 8 5 To load reagent When the screen prompts you to load the cartridge open the reagent carousel door Move the cartridge in...

Page 149: ...Cal Required Loading Reagent Parameters Step Action 1 Select the Rgts Cal icon from the menu bar Note If parameters are loaded as part of the reagent cartridge load proceed directly to Step 3 2 Select Params F2 Note Parameters cannot be loaded if the reagent cartridge is onboard and the system status is Running 3 Once the reagent cartridge is successfully loaded a Load Reagent Parameters dialog bo...

Page 150: ...ers 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 A successfully entered parameter is shown and verified by a check mark 5 Select Done to exit and save information OR Select Clear to delete information Step Action continued 2 of 2 ...

Page 151: ...mended calibration frequency intervals Indicated by control results Defined per your laboratory policy Electronic or module adjustment Calibration set point modification New lot calibrator diskette load Specific maintenance procedures as defined in CHAPTER 10 Maintenance of this manual are performed Calibrations options are identified in the Cal Options box in Figure 5 6 To access a cal option sel...

Page 152: ...ibrator diskette in the calibrator box and follow the procedure below Step Action 1 Make sure the DxC is in Standby 2 Select the Rgts Cal icon from the menu bar 3 Select Cal Options F6 4 Select 1 Load calibrator diskette 5 Verify that the lot number on the diskette is the same as the lot number on the calibrator bottle Insert the diskette into the disk drive Select OK 6 Verify that the lot number ...

Page 153: ... placing a calibrator cup in a tube Step Action 1 Select the Rgts Cal icon from the menu bar 2 Select Assign F7 3 Use the down arrow option button to open list of calibrators 4 Select the calibrator 5 Type in the calibrator s ID or rack position number If using a bar code label the label must match the assigned calibrator ID If a rack position is assigned the calibrator must be placed in this assi...

Page 154: ... Operator initiated allows analysis to proceed on all other chemistries without having to deprogram the bypassed chemistry A bypassed chemistry can be recalibrated but not extended or overridden Cal Failed Indicates that calibrator values for a chemistry have exceeded calibration acceptance limits Cal Timed Out Indicates time remaining has exceeded the recommended calibration period Cal Time Exten...

Page 155: ...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 Table 5 3 Conditions and Highlights for Calibration Status Warnings IF the Calibration Status has THEN the Highlight is Which Means Cal Required Red The chemistry can not be processed now Chem Bypassed Cal Failed Cal Timed Out ...

Page 156: ...istries to be calibrated If necessary use the up and down arrows to select more chemistries 3 Select Cal F4 4 Select List F5 to review the calibrator load list Make sure the lot number on the calibrator bottle agrees with the lot number seen on the screen Make sure the correct bar code labels are in the correct positions 5 Place a calibrator bar code label with the name of the calibrator to be use...

Page 157: ...rator bottle is the same as the lot number on the screen 5 Get the assigned calibrator racks listed on the screen and place the cups into assigned rack positions as shown on the load list 6 Place calibrator into sample cups For Aqua cals 1 2 and 3 fill a 0 5 mL cup All other calibrators need 3 drops of calibrator in a 0 5 mL cup 7 Place the rack 1 in the autoloader 2 with the rack bar code label t...

Page 158: ... the calibration CC Subsystem Calibration Failure The CC subsystem warns the operator of a failed calibration If a chemistry fails there is a pop up message after a completed calibrator level The message includes Calibrator name Chem name Reagent Position MC Subsystem Calibration Failure The MC Subsystem warns the operator of a failed calibration If a chemistry fails there is a pop up message afte...

Page 159: ... must be established from a fresh cartridge The calibration frequency of a particular cartridge has priority over the within lot calibration frequency If a cartridge selected for within lot calibration is still loaded at the end of its individual calibration frequency period that cartridge must be recalibrated this will not affect the within lot calibration factor Enabling Within Lot Calibration F...

Page 160: ...bsequent reagent packs loaded Do you want to save changes to within lot chemistries Within Lot Calibration Status Screen The Within Lot Calibration Status screen has a summary of the within lot calibration time which remains This summary is for the cartridge chemistry lot number combinations that have within lot calibration factors applied E015926S EPS Step Action 1 Select a desired Configured Che...

Page 161: ...ription wf Reagent has been enabled for within lot calibration and the cartridge has been freshly loaded Any wf designated cartridge can be used to establish a within lot calibration factor A cartridge receives this designation if it was loaded onto the system for the first time after within lot calibration was turned on no more than 8 hours have lapsed since it was first loaded onto the system w ...

Page 162: ...n and the cartridge is recalibrated more than 8 hours have lapsed since the cartridge was first loaded it has a w designation and a fresh reagent of the same lot is calibrated for within lot use the calibration status for the reagent becomes Cal timed out within lot calibration expires Table 5 4 Definitions of Within Lot Designations continued Designation Description 2 of 2 Table 5 5 Reagent Calib...

Page 163: ...Kit includes diskettes which provide set points for the selective enzymes Additional Information DGKCh Deutsche Gesellschaft für Klinische Chemie German Clinical Chemistry Association a committee that establishes formulation standards in Europe IFCC International Federation of Clinical Chemistry NOTICE Once the enzyme reagent is configured and loaded and the Enzyme Validator feature is turned on E...

Page 164: ...be removed by successfully recalibrating the chemistry or by selecting Chem Bypass A flag indicating that a particular chemistry has been overridden will appear in the Instrument Code area on the appropriate Summary or Patient Chartable Results report Although a Cal Overridden status can be bypassed the Cal Overridden flag is only removed by a successful calibration NOTICE Overriding a calibration...

Page 165: ...ndby Disabled or Running The system will not aspirate sample or dispense reagents for bypassed chemistries They will not be marked as Pending Bypassed chemistries are logged on the Post Run Summary Report Bypassed chemistries must be calibrated to process samples Bypassing a Chemistry The following table explains how to bypass a chemistry Removing a Bypassed Status Recalibrate the chemistry to rem...

Page 166: ...xtend Cal is not allowed if calibration has already been requested If a chemistry is allowed to time out subsequent results will not be processed however extending the calibration time will allow results to process and print Extending Calibration Time The following table explains how to extend calibration time Removing an Extended Status Calibration extension is indefinite Recalibrate chemistry to...

Page 167: ...enerated Calibration Acceptance provides a reference to the acceptable limits for calibration Viewing Calibrator Acceptance Limits Follow the steps below to view calibration acceptance limits Step Action 1 Select the Rgts Cal icon from the menu bar 2 Select Options F6 3 From the Cal Options dialog box select Calibrator acceptance limits using the pull down menu limits Chemistries appear with chemi...

Page 168: ...y calibrator set points NOTICE Altering a programmed calibrator set point is not usually justified However there may be a situation when a calibration value needs to be reassigned Set Point Modification should not be used routinely to correct instrument correlation The magnitude of error which is deemed acceptable when modifying a set point is totally under the control of the laboratory and theref...

Page 169: ...r chemistry select desired chemistry move cursor to the applicable set point and select Restore Defaults The default values have more significant figures than shown on the screen Therefore select Restore Defaults rather than typing the default values 6 Select Close to exit the screen Calibration status changes to Cal Required Status changes only for those containers with the same lot number A flag...

Page 170: ... derived from statistically significant patient correlation studies It is recommended that patient samples are run over a period of several days by both methods using controls to monitor accuracy A good range of data should be achieved by analyzing below normal normal and above normal samples Patient sample data only should be used for linear regression analysis with Synchron values as y values an...

Page 171: ...set adjustment using the pull down menu 4 Move cursor to the slope and or offset to be modified OR Use Page Up or Page Down from the screen or the keyboard counterparts to locate the Chem Type the desired value If a previously modified slope or offset is to be returned to the original default value for that calibrator or chemistry select desired chemistry move cursor to the applicable field and se...

Page 172: ...ry per report format This prevents duplicate copies For example if NA is selected the report contains all five ISE chemistries Step Action 1 Select the Rgts Cal icon from the menu bar 2 Select the chem position s to print 3 Select Options F6 4 From the Cal Options dialog box select Print cal report using the pull down menu 5 From the Print Cal Report dialog box select 1 Current Cal Report using th...

Page 173: ... performing real time analysis of control data The QC data is presented in both a summary format and in a chart format Westgard QC rules are applied to the data to aid in determining chemistry and system reliability Determination of QC Flags The DxC uses the Z score method for standardizing the scale of a normally distributed measurement variable For an individual control result the Z score repres...

Page 174: ...evious Result In addition the Z score for the current result is compared with the Z score of the previous result in the same QC file If both Z scores are beyond 2 SD on the same side of the assigned mean the current result receives an Accuracy flag on the QC Log report this flag signifies a violation of the 2 2S rule These values appear red in the QC log and QC chart If the two results being compa...

Page 175: ...rom one or two levels were more than 1 SD from the mean in the same direction 10X Within or Across Last Ten Results of One or Two Levels of Control Were All on the Same Side of the Mean This rule judges the result out of control if the last ten results from one or two levels were all on the same side of the mean Figure 6 1 QC Accept Reject Chart Using Westgard Rules When defining controls Control ...

Page 176: ...ition however the system will allow different pre treated samples to be defined in the same control Pre treated samples i e HDLC IBCT diluted samples or samples of different sample types should be defined as separate controls with their own bar codes Drugs of Abuse Test chemistries have the cutoff value printed in the control range column of the control report The POSITIVE or NEGATIVE flag is prin...

Page 177: ...20 alphanumeric characters Note When defining control names avoid the following characters used by ASTM standard delimiters Vertical bar Back slash Caret Ampersand 5 Type the control lot number in the Control Lot No field The control lot number has a maximum of 12 alphanumeric characters 6 If Serum Indexing is desired select the Serum Index check box A check designates an enabled serum index For a...

Page 178: ... all chemistries shown Field Description QC File Number Type a QC file number for each chemistry The QC file number must be a unique 3 digit number from 1 to 999 If a QC file number has already been assigned the system will not accept it a second time Refer to Displaying QC File Lists in this chapter to obtain a list of used QC File numbers Assigned Mean Type the assigned mean for the chemistry le...

Page 179: ... definition is not complete a warning message will appear specifying which information is missing The operator has the option of exiting the control definition screen or returning to the definition screen to add the missing information If exiting the definition screen without filling in the missing fields the following will occur Exiting the screen without QC File Number not fully defined will del...

Page 180: ... codes Printing Bar Code Assignments Press the Print Screen key to print the Control ID assignment window Step Action 1 From the Define Edit Screen select Control ID F2 2 The Control ID dialog box comes into view A maximum of eight unique bar code IDs with a maximum of 15 alphanumeric characters may be entered Press the Tab key after each bar code entry to move between fields When creating Control...

Page 181: ...automatically run all cartridges onboard and runnable for any chemistries for an auto generated control To enable Multiple cartridge from the Set up screen scroll down and select 29 Auto Generation of Control 3 Press the RUN button on the analyzer The instrument automatically runs chemistries that are Defined for the control Loaded and calibrated Contain sufficient volume to run the controls 4 If ...

Page 182: ...to be run Note In Manual QC Programming the system automatically runs the oldest cartridge onboard for the selected chemistry If multiple cartridges are on board duplicates are available for selection Specific cartridges other than default may also be selected To access duplicate or specific cartridges select Rgt Cart F8 Then select the desired cartridges and select OK 6 Select Save F10 to save th...

Page 183: ...enu bar 2 Select the control option number beside the Control Name and select Define F2 3 Select the chemistry field for modification 4 Type the modified assigned mean standard deviation 1 SD or constituent code 5 A Define Edit Control dialog box prompts the operator to choose how the changes will be applied to subsequent data Select the desired option or type the item number of the desired action...

Page 184: ...ted Reviewing a QC Follow the steps below to review a control previously defined Step Action 1 Select the QC icon from the menu bar 2 From the QC Screen select a control number 3 Select Review F1 4 All current information and selected chemistries appear including serum indices Control ID F2 can be accessed to view the eight bar code IDs Delete Control F3 can be used to clear a control Select Print...

Page 185: ...view QC functions Deleting a Control Follow the steps below to delete a previously defined control Step Action 1 Select the QC icon from the menu bar 2 Select the control to be cleared 3 Select Delete F3 4 The following message appears to confirm the clearing of the selected control All QC files for control will be deleted Archiving is suggested Delete this control Select OK to delete the control ...

Page 186: ...anges Introduction The entire database of controls may be printed Printing QC Ranges Follow the steps below to print QC ranges Step Action 1 Select the QC icon from the menu bar 2 Select the control to be printed or type the item number 3 From the QC screen select Print F10 4 To print additional control ranges repeat Steps 2 and 3 ...

Page 187: ...trol in this chapter A control can be associated with one or more QC files Displaying QC File Lists Follow the steps below to list QC files Step Action 1 Select the QC icon from the menu bar 2 From the QC screen select List F4 3 If no control is selected the system shows all chemistries in all controls with chemistries in alphabetical order The QC File list appears with all defined controls listed...

Page 188: ...ugh System Setup Accessing the QC Summary Follow the steps below to either access or print the QC summary Step Action 1 Select the QC icon from the menu bar 2 A list of currently defined controls appears Select the control for the QC Summary or type the item number and press Enter 3 Select Summary F6 from the QC screen 4 Type a Start date and an End date using the dd mm yy format The default Start...

Page 189: ...hard disk or the floppy disk Note Color flagging is based on assigned mean and SD at time of run If assigned mean and or SD are modified flag color will not change Accessing QC Charts Follow the steps below to access QC charts Step Action 1 Select the QC icon from the menu bar 2 From the QC screen select a currently defined control or type the item number of the desired control for viewing 3 Selec...

Page 190: ... Select the chemistries to chart Multiple selections are allowed Use the scroll bar to access additional chemistries Note User defined chemistries which have been cleared cannot be retrieved for QC Chart Select OK to show the QC Chart s Select Cancel to cancel the Chart request 6 Select Next F8 to access all requested QC charts Each of the requested charts will show in the order of the control che...

Page 191: ...t the QC icon from the menu bar 2 Select the control desired or type the item number of the control and press Enter Use the scroll bar to access additional controls 3 Select Log F5 from the QC screen 4 Type a Start date and an End date in the date range fields The default Start End date is the current date Select OK to select the default Press the Tab key to toggle between fields Select OK to cont...

Page 192: ...2 of 2 NOTICE QC data points should only be deleted when the system is in Standby or Stopped state Deleting a chemistry data point from a QC control file that has the same chemistry control combination actively running on the system may cause the system to update the QC files incorrectly Step Action 1 Select a data point by selecting the check box next to the data point 2 Select Delete F3 3 Type t...

Page 193: ...ia however it is not grayed out If the feature is selected for external media no error message will show Step Action 1 Select a data point by selecting the check box next to the data point 2 Select Action F4 3 Type the password if secured and ID initials 4 The QC Action Log appears There are 30 characters in the field Write a comment about the data point Select OK to save the comment OR Select Can...

Page 194: ...File number of the new result in process the new result will not be saved The operator will be notified that the new result was not saved When this dialog box notification appears it may be appropriate to archive How to Archive QC Follow the steps below to archive Current QC Data to a floppy diskette NOTICE Diskette must be Double sided High Density Step Action 1 Select the QC icon from the menu b...

Page 195: ...ober 2005 Page 6 23 6 7 Select OK or Cancel Note If the operator answers OK to the delete QC data prompt a warning appears 8 Press Enter to initiate deletion 9 Select a date interval for QC data deletion by typing a Start date and an End date in the date range fields Step Action continued 2 of 2 ...

Page 196: ...iew QC data after it has been restored Step Action 1 Select the QC icon from the menu bar 2 Select Archive F8 from the QC screen 3 Select 2 Review Disk or type 2 and press the Enter or Tab key 4 Insert the archive disk and select OK at the prompt 5 Information about the archive disk date archived operator ID start date end date appears If the information indicates that the proper disk has been ent...

Page 197: ...ived control definition QC File List F4 to view and Print archived QC File lists Log F5 to view the Log for the archived data Summary F6 to view and print a summary of the archived data Chart F7 to view a specific archived control chart Print Controls F10 to print archived control ranges Refer to the appropriate sections for specific instructions on each of the listed functions Step Action continu...

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: ...ample Type Sample Comment Patient ID and Patient Demographics functions The Sample Options feature allows modification of the sample replicates modification of the test replicates entry of an off line dilution factor select deselect serum index and programming of a manual ORDAC A sample can be designated as a Control sample or as a STAT for priority processing Samples can also be programmed in a b...

Page 200: ...g how many positions within a rack are available for programming Racks can be viewed and cleared from this screen Only manually assigned samples or calibrators need to be cleared from racks Step Action 1 Select the Samples icon from the menu bar 2 Select Racks F8 3 Select a rack or type a specific rack number in the Rack field to view Sample Status Refer to Table 7 1 Sample Status Designations for...

Page 201: ...ator Screen for additional information on Sample Carousel status 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 Complete All tests have been completed Reserved for Cal Rack Position assigned to a calibra...

Page 202: ...t is required but both can be entered Refer to CHAPTER 4 System Setup Bar Code Setup for additional information on setting up sample identification features If a rack has a readable bar code and a manual rack position assignment for the same sample position the system verifies that the bar code and the manual assignment match If there is a discrepancy the rack will be offloaded and the operator no...

Page 203: ...mples run as calibrators Examples WARNING IF YOUR LIS OR NORMAL WORKFLOW REQUIRES THE REUSE OF SAMPLE IDs THE SAMPLE PROGRAMMING SHOULD BE CLEARED FROM THE DxC AT A TIME INTERVAL THAT IS LESS THAN THE SHORTEST TIME OF SAMPLE ID REUSE THE DxC OVER WRITE FEATURE IS NOT SUFFICIENT FOR SUCCESSFULLY REUSING SAMPLE IDs IF THIS WARNING IS NOT FOLLOWED RESULTS FROM THE NEW REQUEST WILL BE MERGED WITH TEST...

Page 204: ... set up in bar code mode and a sample will not be bar coded OR a bar code is unreadable by the system Step Action 1 Select the Samples icon from the menu bar 2 Select Racks F8 3 Select a rack with an open position Type the desired manual assignment into the selected rack position 4 Select OK to accept the assignment Cancel to leave assignment screen 5 Select Program F10 to return to Sample program...

Page 205: ... Chemistry Identifiers Color is used to indicate chemistry information The chemistry name appears in red when the chemistry is not runnable There are two possible reasons why a chemistry can not be run The reagent is not loaded or A loaded chemistry has a reagent or calibration status that does not permit it to run Refer to the Reagent Calibration Status screen for the reason the cartridge can not...

Page 206: ...al ORDAC For samples with analytes of known concentration that exceed the analytic range the manual ORDAC feature may be selected ORDAC compensates for extremely high concentrations by taking either a smaller sample volume or diluting the sample on line Selecting manual ORDAC in Sample Programming sends the request to run the test in ORDAC the first time it is run unlike chemistries selected for A...

Page 207: ...ode is complete when End Batch is requested or upon exiting the Sample Program screen Batch Programming Batch programming in rack and position mode can be performed using the following procedure Step Action 1 Select the Samples icon from the menu bar 2 Select the tests sample type and any other data that is common for all samples in the batch including sample options information 3 Select Batch F4 ...

Page 208: ...c Sample IDs Sample IDs only Select Sample IDs Only button Type specific Sample IDs Select Racks F1 to assign specific racks to the IDs or leave rack positions empty Rack Pos only Type the rack numbers and number of samples desired in the batch only Do not type Sample IDs 6 To end Sample ID entry and to save the batch programming select End F10 Note Patient demographics may be entered for a partic...

Page 209: ...cleared results cannot be recalled by Sample ID Results may still be recalled by other demographic information To avoid retrieving inconsistent sample data recall results using Sample ID or verify correct Sample ID when recalling by rack and position Results for the last sample run in a specific rack cup position will be recalled Results for the new sample will be available for recall only after t...

Page 210: ...ps below to enter Sample IDs for recall Step Action 1 Select the Results icon from the menu bar 2 To input Type an individual Sample ID the Sample ID desired for recall in the Sample ID field a range of Sample IDs the Sample ID at the beginning of the range in the From field Press the Tab key Type the Sample ID at the end of the range in the To field Press Enter 3 Select a function button from the...

Page 211: ...er the rack number s desired for recall in the Rack field 1 999 Numbers can be separated by a comma to define a series and or by a dash to define a range Example 1 2 5 8 3 If Then one rack number is entered press the Tab key to access the Pos s field Type the position numbers desired for recall 1 4 Numbers can be separated by a comma to define a series and or by a dash to define a range If one rac...

Page 212: ...the bottom of the screen to select a desired output option Results F1 to view results on the screen Sum F7 to send statistical summary to printer Host F8 to send results to the host Print F10 to send results to a printer For additional information refer to Displaying Recalled Results Printing Recalled Results and Sending Results to the Host in this chapter Step Action continued 2 of 2 ...

Page 213: ...atient ID Step Action 1 Select the Results icon from the menu bar 2 From the Recall Results By screen type the Patient ID a maximum of 15 alphanumeric characters in the Patient ID field Only one Patient ID may be requested at a time 3 Select a function button from the bottom of the screen to select a desired output option Results F1 to view results on the screen Sum F7 to send statistical summary ...

Page 214: ...button from the bottom of the screen to select a desired output option Results F1 to view results on the screen Sum F7 to send statistical summary to printer Host F8 to send results to the host Print F10 to send results to a printer Table 8 1 Date and Time Formats with Recall Results Field Entries Notes Date 1 12 mm 1 31 dd 0 99 yy An entry in the From field is required If only a From date is ente...

Page 215: ...ed in this chapter 2 Select Results F1 to view requested samples 3 Use the Up or Down arrows to view additional pages of the same sample 4 If there are tests running Recall F2 is available Select Recall F2 to update the sample on the screen with new results since the sample was first shown 5 Select Prev F3 to view the Absorbance versus Time plot OR Select F4 to edit OR Select F6 to send results to...

Page 216: ...ive or both negative delete the second result Deleting a Critical Rerun Result Follow the steps below to delete one of the two results of a sample which was rerun with Critical Result Rerun Step Action 1 From the Recall Results By screen select the results to be viewed as previously described in this chapter 2 Select Results F1 to view requested samples 3 Use the Up or Down arrows to view addition...

Page 217: ...C Systems Instructions For Use A13914 Results Recall October 2005 Page 8 9 8 8 Select Prev F8 to view a previously shown sample OR Select Next F9 to view other samples if more than one sample result was recalled OR Select Done F10 when completed Step Action continued 2 of 2 ...

Page 218: ...esults print on subsequent pages Step Action 1 Select the Results icon from the menu bar 2 To print using Then Default report format Go to Step 4 Patient Multi Sample report format Continue with Step 3 3 If Patient Multi Sample Report box is selected input specific Patient ID Select Print F10 Select samples to be compiled into report All selected Patient Results will be compiled into a single repo...

Page 219: ...sults How to Send Parcels of Data Follow the steps below to recall results to the host Step Action 1 Select the Results icon from the menu bar 2 To send Type groups of data range of racks patient ID or name run date time doctor name or patient location and select Host F8 individual sample data the Sample ID patient ID or name run date time doctor name patient location for sample or racks and cups ...

Page 220: ...elected chemistries are highlighted next to the chemistry name 3 Select ABS F3 Note The Absorbance vs Time Plot is shown for the first selected chemistry 4 To see the Absorbance Plot Summary Data select the down arrow 5 To output Select A file to a diskette Done F10 to exit the screen Then select Disk F1 Absorbance vs Time Plot and Absorbance vs Time Table to a printer Both Either Absorbance vs Ti...

Page 221: ... Information The maximum number of samples that may be recalled is 100 If more than 100 samples are recalled the instrument will Show Exceeds maximum limit Not all samples will print Not print statistics for all samples Displaying Statistical Summary Follow the steps below to view results on the screen Step Action 1 Select the Results icon from the menu bar 2 Type the range of desired results use ...

Page 222: ...Statistical Summary Report Displaying Statistical Summary Results Recall UniCel DxC Systems Instructions For Use A13914 Page 8 14 October 2005 ...

Page 223: ...d methodology A set of parameters must be defined which fully characterizes an analyte Once defined the parameters are stored in memory according to the test name designated in 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 ...

Page 224: ... marked with the reagent name and expiration date The maximum and minimum fill volumes required to allow for accurate level sensing are indicated in the table below Table 9 1 Fill Volumes for Accurate Level Sensing Compartment A Compartment B Compartment C Maximum Fill Volume 110 mL 18 mL 4 mL Minimum Fill Volume 6 mL 1 mL 0 3 mL NOTICE Since Beckman Coulter does not manufacture or otherwise contr...

Page 225: ...lter 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: ...u bar 2 Select 15 User Defined Chemistries 3 Select the Number to be defined OR Type a number in the Option Number field and press Enter 4 Select Define F1 5 Type information for the user defined reagent as defined on the following screens Chemistry Parameters Processing Parameters Error Detection Limits 6 When complete select an icon from the menu bar for the next desired action If an area is inc...

Page 227: ... detailed explanation of each type Table 9 2 Allowable Entries for a Chemistry Test Name A maximum of four alphanumeric characters including Note The first character must be an alphabetical character Table 9 3 Reaction Type Options Reaction Type Description Endpoint 1 Blank absorbance is not subtracted from Reaction 1 absorbance Endpoint 2 Blank absorbance is subtracted from Reaction 1 absorbance ...

Page 228: ...direction indicates increasing absorbance with time A negative reaction direction indicates decreasing absorbance with time Table 9 4 Options for Units 1 mg dL 11 µg mL 21 IU mL 31 negative 41 mg mL 2 mg L 12 ng mL 22 U mL 32 pg mL 42 ng L 3 g dL 13 µg dL 23 Rate 33 pg dL 43 RLU 4 g L 14 µg L 24 ng dL 34 pmol L 44 S CO 5 mmol L 15 nmol L 25 µIU mL 35 Uptake 45 AU mL 6 µmol L 16 U L 26 mIU mL 36 GH...

Page 229: ...s used for flash correction of the primary absorbance values The primary and secondary wavelength cannot be equal 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 Math Model 8 Alternative to Model 2 5 Parameter Logit function Math Model 9 Extension to Model 1 4 Parameter Log lo...

Page 230: ...ate factor for rate chemistries a derivation of the Beer s Law formula as applied to bichromatic chemistries can be used as follows where e1 The extinction coefficient of the chromophore at the primary wavelength e2 The extinction coefficient of the chromophore at the secondary wavelength Extinction coefficients for the chromophore MUST be obtained from the reagent manufacturer or determined exper...

Page 231: ... order low to high This will facilitate proper placement of the calibration samples on the rack since the load list does not denote the cup order of the user defined calibrators All other values will be disregarded Calibration Time Limit Calibration time limit is the number of hours the chemistry can be run before recalibration is required If this time is exceeded the chemistry cannot be run This ...

Page 232: ...minimum volume for First Inject is 200 µL Second Inject Component The Second Inject component designates the compartment of the cartridge which will be pipetted second If Second Inject is not used the compartment selection is None and should not be modified Second Inject Dispense Volume The combined volume of all inject reagents must be between 200 µL and 327 µL Table 9 14 Options for the First In...

Page 233: ... 1 second however the reagent will be added at the 8 second interval closest to the time defined Sample addition occurs at 1 second A positive number indicates a Second Inject reagent component is added after sample add An add time value of 180 will dispense reagent at the same time as First Inject reagent component Table 9 18 Allowable Entries for Add Time for the Second Inject 180 9 to 738 secon...

Page 234: ...2 October 2005 Figure 9 1 Timing Chart TIME SECONDS Reagent Blank Read Window Reaction Read Windows E011407L EPS Cuvette Wash Completed Primary Reagent Fill Sample Inject Cuvette Wash T 180 T 172 T 0 T 9 T 738 3 to 6 minutes DxC 600 800 Timing Chart Second Inject Add Time T 180 9 to 738 Third Inject Add Time T 172 9 to 738 ...

Page 235: ...onds after reagent s and or sample have been pipetted Time is entered in increments of 1 second however the reagent will be added at the 8 second interval closest to the time defined Sample addition occurs at 1 second A positive number indicates Third Inject reagent component is added after sample add Third Inject add time must be greater than Second Inject add time Sample Volume Total volume of s...

Page 236: ... be at least 8 seconds greater than the start time If the initial read times are not entered the default values are defined as follows Reaction starts with sample addition sample is added at cycle 1 Initial read starts at cycle 1 and ends at cycle 2 Reaction starts with trigger reagent trigger reagent is added at cycle N The initial read starts at cycle N and ends at cycle N 1 Reaction Read Times ...

Page 237: ...strument range high OIR HI respectively if these ranges are exceeded Table 9 25 Reaction Read Times Allowable Entries Single Cycle Test Double Cycle Testa a 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 Start Read 1 to 1704 seconds 1 to 1604 seconds End Read 1 to 1720 seconds 721 to 1620 seco...

Page 238: ...m absorbance or rate method dependent measured during the reaction read window For upgoing rate or endpoint reactions if the reaction absorbance is less than the Low Limit then results will be suppressed and flagged as RX ABS LO Likewise if the High Limit is exceeded the result is suppressed and flagged RX ABS HI For downgoing rate methods the Low Limit indicates the maximum rate observed during t...

Page 239: ...going reactions the initial rate should be a negative number Multipoint Spans Multipoint span limits specify the allowable difference in absorbance or rate between respective multipoint calibrator levels 1 and 2 2 and 3 3 and 4 4 and 5 5 and 6 6 and 1 Values will only be shown for the number of calibrators specified under of Calibrators A change in calibrator number will reset the spans to zero 0 ...

Page 240: ... to the primary wavelength as possible without overlapping the spectral curve of the desired chromophore The secondary reference wavelength should be near the base of the analytical absorption curve If the wavelength selected resides on the spectral curve a loss of sensitivity may result In order to minimize any optical interference due to the presence of another absorption curve the selection of ...

Page 241: ... 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: ...of determining extinction coefficients is suggested For additional information refer to Textbook of Clinical Chemistry Norbert W Tietz 1999 Option 2 Prepare the reagent according to the manufacturer instructions With a manual spectrophotometer or automated instrument obtain the delta absorbance per minute on at least ten replicates of a normal or high normal sample at each of the appropriate wavel...

Page 243: ...be unique no two calibrator levels can have the same analyte target value setpoint Models 1 2 3 8 9 and DAT do not support negative setpoints If the math model is either Model 1 or Model 9 the number of calibrators must be five or six levels only If the math model is Model 2 Model 3 or Model 8 the number of calibrators must be exactly six levels If the math model is DAT the number of calibrators m...

Page 244: ...eater than zero Reagent volumes of 0 µL indicate a volume that is not set The sample volume must be greater than 0 µL The sum of all reagent volumes added prior to the reagent blank read must be greater or equal to 200 µL The sum of sample volume and all reagent volumes must not exceed 330 µL The first second and third reagent inject components must be from different compartments of the reagent pa...

Page 245: ...menu prior to removal Step Action 1 Remove UDR reagent cartridge from system 2 Delete UDR information from the following areas reference ranges calibration assignments sample programming and quality control 3 Select the Setup icon from the menu bar 4 Select 2 Chem Config Sample Type 5 Select the Option No of the chemistry to be deleted 6 Select F6 Delete to remove the UDR from the chemistry menu 7...

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: ...ed in some laboratories A start up prime of the various subsystems may be necessary if the system has been idle for more than approximately 8 hours Refer to CHAPTER 12 Utilities for priming procedures Reviewing reagent status prior to running the instrument is standard laboratory practice As with any laboratory equipment the exterior of the DxC system should be kept clean Any spills should be clea...

Page 248: ...ctly Maintenance is scheduled at the following intervals Weekly Monthly Two Month Three Month Four Month Six Month This maintenance schedule is developed for all systems Following specific maintenance procedures running calibration and controls may be required Weekly Maintenance Check Reagent Levels Replace Cuvette Wiper Clean Total Protein and Albumin Cups DxC 800 only Clean Probes Exterior Clean...

Page 249: ...er 2005 Page 10 3 10 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 Replace Glucose Sensor ...

Page 250: ...tly to the maintenance items that need attention a yellow DUE indication will also have the following affect on the screen From any screen the Utilities icon wrench will be yellow After selecting Utilities the Maintenance option option 2 will be yellow When the Maintenance option is selected and the Scheduled Maintenance Log screen appears The tab s requiring action will also be highlighted in yel...

Page 251: ...eted The definitions for each number is are 0 No action required 1 Run Controls If controls are within specifications no more action is necessary If controls are out of specification calibration or routine troubleshooting may be necessary Usually verifying that there are no leaks or loose components due to maintenance resolves the issue 2 Calibrate the affected assays and run controls If controls ...

Page 252: ...tem from being run In order to provide a pathway directly to the maintenance items that need attention a yellow DUE indication will also have the following affect on the screen From any screen the Utilities icon wrench will be yellow After selecting Utilities the Maintenance option option 2 will be yellow When the Maintenance option is selected and the Scheduled Maintenance Log screen appears the ...

Page 253: ...counter will reset for the appropriate time interval Print Once a time period Month and Year has been entered this button prints all of the maintenance tabs and associated maintenance data Delete If desired the operator can use this option to delete old maintenance information based on a date range Approve This option allows a separate review and approval by allowing the reviewer to enter their in...

Page 254: ...S Auto Gloss bottle is in a bracket on the inside of the middle door 4 Examine the reagent levels in the bottles and compare them with the percentages on the screen Wash No Foam and Auto Gloss 5 If the volume shown does not match the actual reagent volume enter the correct volume for each reagent in the Vol field Note There is a pop up window when approximately 10 and 5 of an MC reagent remains 6 ...

Page 255: ... weekly or as needed to maintain the cleanliness and integrity of the cuvette Step Action 1 Remove the cuvette wash station cover Pull up on the two locking pins 1 Pivot the right side of the cover turning it forward Lift out the cover being careful not to disturb the CC sample mixer Figure 10 1 2 Remove the two thumbscrews 1 on each side of the cuvette washer Lift off the upper section of the cuv...

Page 256: ...the cuvette The under surface of the wiper should be flush with the end of the washer probe Figure 10 3 4 Replace the upper section of the cuvette wash assembly and tighten the thumbscrews finger tight Make sure the wash assembly is seated properly on the mounting pins 5 Verify that all four wash tower probes are centered over a cuvette Failure to do so may cause a flood 6 Reinstall the cuvette wa...

Page 257: ...ns 2 Select Rinse The cups are drained and rinsed 5 times with water A Result window appears DO NOT close this window at this time 3 When rinsing is complete use a transfer pipette to manually add One mL of 1N HCL solution to the Total Protein cup One mL of 10 Cleaning solution to the Albumin cup 4 Let the cleaning solution sit in the cups for 10 minutes The stir bars will continue to stir during ...

Page 258: ...Bm and TPm lamp calibration following the Weekly maintenance Step Action continued 2 of 2 CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when performing this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter Step Action 1 Press the STOP button on the instrument to place the system into Stopped state ...

Page 259: ...robes under the attached wash collars remove the reagent carousel cover then Move the reagent probes from the home position to the maintenance indentation 1 Press the probe down into the depression Wipe the outside portion of the exposed probe Carefully release the probe and allow the probe to return to its home position Figure 10 4 Step Action continued 2 of 3 A015937P EPS 1 ...

Page 260: ...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 Press the probe down into the clear area Wipe the outside portion of the probe Figure 10 5 5 When all maintenance steps are complete reinstall covers and select OK to clear the pop up message the Instr Cmd icon from the menu bar 1 Home Step Act...

Page 261: ...rogrammed for 10 replicates of CCWA Note The Serum Index option SHOULD be disabled in order to proceed with the cleaning procedure Material Required Diluted Clenz Solution freshly prepared by adding 2 drops of Clenz Solution P N 664090 to an empty 2 mL sample cup Fill to 1 mL line with saline and mix 0 9 Saline CCWA cartridge P N 657133 Cleaning Procedure Step Action 1 Select the Utils icon from t...

Page 262: ...Next F10 to continue programming for all desired positions Select CCWA for wash solution Example of programming replicates Rack Sample Position Chemistry Replicates Fluid 1 1 CCWA 15 Diluted Clenz Solution 2 CCWA 10 Saline 8 Place diluted Clenz Solution and saline into the appropriate rack and positions 9 Load a sample rack onto the system and press the RUN button on the instrument Note Ignore the...

Page 263: ... page 2 of the calibration report Check the CL span value at the bottom of the page If the value is 1800 the CL electrode tip needs to be replaced Replace the electrode tip when it is convenient to your work load Instructions for preparing and replacing the CL electrode tip are found in the Replacing the Chloride Electrode Tip procedure in the As Needed As Required Maintenance section of this chap...

Page 264: ... module until it clicks The locking pin is located on the left side of the ISE module on DxC 800 Systems as shown below The locking pin is located on the right side of the ISE module on DxC 600 Systems Figure 10 6 3 Unscrew and remove the bottle cap from the alkaline buffer reagent Hold the cap with attached straw over a container that will catch the residual fluid from the alkaline buffer return ...

Page 265: ...re 10 7 6 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 7 After installation of the filter is complete reattach reagent input line 30 that flows into damper to the top of the filter 8 Select the Rgts Cal icon from the menu bar 9 Select MC Rgts 10 Select Load F...

Page 266: ...sing the keyboard Refer to CHAPTER 5 Reagent Load Calibration in this manual 13 Select Done F10 when finished 14 While alkaline buffer reagent is priming observe peri pump tubing and line for leaks Correct the problem if leaks are observed 15 NOTICE If the fluid level of the Alkaline Buffer Damper Assembly requires adjustment proceed to Adjusting Fluid Level of the Alkaline Buffer Damper Assembly ...

Page 267: ...the damper in a horizontal position Note The damper should be positioned so that the output line 29 2 leading from the damper to the flow cell is oriented on top Figure 10 9 3 Prime alkaline buffer five times or as many times as necessary to fill the damper one half full Access alkaline buffer priming by selecting the Utils icon from the menu bar 1 Prime MC F4 ISE CO2 Alkaline Buffer Type 5 in the...

Page 268: ...ove the MAX line 8 Remove input line 30 1 feeding into the damper Using a clean transfer pipette remove excess reagent until damper is one half full Discard the removed fluid Reconnect input line 30 to the damper wipe dry any reagent spill on the damper top Figure 10 10 9 Prime the alkaline buffer three times by selecting the Utils icon from the menu bar 1 Prime MC F4 ISE CO2 Alkaline Buffer Type ...

Page 269: ... 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 Table 10 1 Cup Cleaning Preparation MC Module Prepare By Diluting ALBma BUNm UREAma GLUCmb PHOSma a ALBm BUNm UREAm GLUCm PHOSm CREm and TPm cup modules are used on DxC 800 Systems b Only the GLUC...

Page 270: ...N HCL solution to each of the cups TPm and CREm 4 Let the cleaning solutions sit in the cups for 10 minutes The stir bars will continue to stir during this time 5 At the end of the 10 minute waiting period select Close to exit the Result window 6 Select Rinse All chemistries should already be selected The cups are drained and rinsed 5 times with water 7 When rinsing is complete select Close to exi...

Page 271: ...ntenance 4 Cup Maintenance 2 Select BUNm UREAm to be drained in preparation for maintenance if performing BUNm UREAm maintenance Select Drain A pop up confirmation window will appear to indicate that the cup has been drained and is ready for maintenance Step Action 1 Loosen the two Phillips screws on the ISE module cover and remove the cover 2 Loosen the screws 1 on the MC cover and gently remove ...

Page 272: ...he 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 4 Unscrew the BUNm UREAm electrode retainer nut 1 and withdraw the electrode retainer assembly from the chemistry reaction cup Figure 10 13 Step Action continued 2 of 5 ...

Page 273: ...ver 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 in this chapter 6 Remove the quad ring 4 from the front face of the electrode CAUTION Avoid scratching gold coating on face of electrode as excessive scratching may adversely affect performance Figure 10 14 7 Rinse the quad ring in deionized ...

Page 274: ...0 Using lintless tissue saturated with deionized water clean the electrode mounting port 11 Using dry lintless tissue wipe the electrode mounting port 12 Reinstall the quad ring on the face of the electrode 13 Reinstall the retainer and retainer nut on the BUNm UREAm electrode 14 Rotate the electrode until the electrode key enters the retainer keyway and reinstall the retainer nut on the electrode...

Page 275: ...e Result window and select Cancel to return to the maintenance window If the BUNm UREAm electrode maintenance was performed wait 15 20 minutes to allow for thermal equilibration Calibrate BUNm UREAm Immediately prior to calibration wrap the tip of an applicator stick with lintless tissue to ensure there are no bubbles in the BUNm UREAm cup only Insert the end of the stick into the bottom of the cu...

Page 276: ...rt The calibration process will begin and continue for 5 7 minutes and will end with a pass fail indication If lamp or sensor calibration fails repeat calibration and check to see that cups fill with water If the cup is full and the calibration fails the lamp or sensor may need to be replaced Select Close to exit the CUPs Lamp Sensor Calibration screen Refer to Six Month Maintenance procedures in ...

Page 277: ...pyl alcohol and lintless tissue Inspect mixers for scratches or nicks and replace if necessary Step Action 1 Carefully replace MC cover over reaction cup modules and tighten screws 2 NOTICE While the ISE cover is removed for maximum efficiency the Adjusting Fluid Level of the Alkaline Buffer Damper Assembly procedure in this chapter can be performed Reinstall the ISE module cover and tighten screw...

Page 278: ...Piercer blade approximately once a month If the system runs 500 samples per day replace the blade more frequently The blade count records the number of caps pierced by the blade Refer to CHAPTER 11 System Status and Commands Figure 10 17 Cap Piercer Blade 1 CC Sample Mixer 2 CC Reagent Mixer A015939P EPS 2 1 CAUTION The Cap Piercer blade is very sharp and has been exposed to potentially biohazardo...

Page 279: ...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 1 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 OR To exit this screen select Cancel 2 The instrument prepares for blade replacement Then the Maintenance Conf...

Page 280: ...lade are very sharp and extend below the Wash Tower Stay away from the bottom of the Wash Tower CAUTION DO NOT select OK when the cover is removed This would move the Cap Piercer Carriage up and cause a pinching hazard Fully loosen the two captive Cap Piercer cover screws 1 at the base of the Cap Piercer cover Lift and remove the cover Figure 10 18 Step Action continued 2 of 4 A014462P EPS 1 ...

Page 281: ...ints of the blade Lift up the blade to remove it Discard the old blade into a biohazard sharps container 6 Note The points of the blade are very sharp Remove a new blade from its container 7 Hold the blade holder with the blade hole on the top Note that the blade hole is keyed and the blade has a slot Install the blade into the blade holder as follows Rotate the blade if necessary until it falls i...

Page 282: ... two captive blade holder screws Tighten the captive blade screw 9 Install the Cap Piercer cover and tighten the two captive Cap Piercer cover screws 10 Select OK The system sets the blade count to zero The Cap Piercer carriage moves up to home position 11 Simulate the load of CTS Auto Gloss Lubricant by clearing and resetting the values on the Auto Gloss screen at Reagent Load From the MC Reagent...

Page 283: ...rced by the blade Refer to CHAPTER 11 System Status and Commands Figure 10 20 Cap Piercer Blade with CTS Auto Gloss Wick Material Required Medium Phillips screwdriver Small Phillips screwdriver Medium straight edge screwdriver Replacement Procedure In the following procedure the old blade and wick is removed in Steps 1 5 and the new blade and wick is installed in Steps 6 10 CAUTION The Cap Piercer...

Page 284: ...reen select Cancel 2 The instrument prepares for blade and wick replacement Then the Maintenance Confirmation Window comes into view 3 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 when the cover is removed This would move the Cap Piercer Carriage up and cause a pinching hazard Fully loosen the tw...

Page 285: ...ber 2005 Page 10 39 10 4 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 Fully loosen the two captive blade holder screws 1 Remove the blade holder 4 Unclip the wick 5 Figure 10 22 Step Action continued 2 of 5 A015940P EPS 2 3 4 5 1 ...

Page 286: ...ry to release the wick from its socket Do not touch the wick because it contains CTS Auto Gloss lubricant which is very slippery and difficult to clean The wick 3 should be attached to the blade Discard the old blade clamp blade and wick into a biohazard sharps container Figure 10 23 6 Refer to Figure 10 23 Note A new blade is shipped with a wick attached The points of the blade are very sharp The...

Page 287: ...m the points 6 of the blade Do not touch the points of the blade Figure 10 24 8 Refer to Figure 10 22 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 1 and align them over their holes Slowly lower the blade through the alignment slot until the blade holder screws are in their holes Be careful not t...

Page 288: ...tion The system primes the wick with CTS Auto Gloss lubricant Step Action continued 5 of 5 NOTICE To minimize system down time it is recommended to keep on hand a clean set of air filters Dirty filters can then be cleaned at a convenient time A second set of filters are supplied with the system to use an alternate Step Action Changing Filters 1 Open all lower compartment doors left middle and righ...

Page 289: ... instrument when doors are closed Figure 10 25 Cleaning Filters 4 CAUTION Do not place a damp filter back on the system Residual moisture may cause damage to the system A second set of filters are supplied with the system to use an alternate Vacuum or brush each filter thoroughly to remove dust If excessively dirty rinse with deionized water Vigorously shake residual water from filters Allow the f...

Page 290: ... 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 Figure 10 26 CC Reagent Syringe 500 µL CAUTION To prevent damage due to electrical static discharge ESD wear a wrist ground strap when performing this procedure For further instructions refer to Bas...

Page 291: ...om of the syringe barrels Follow the steps below to activate the automated Syringe Rod Replacement procedure 1 MC Sample Syringe 2 CC Sample Syringe NOTICE The system status must be in Standby to access the Maintenance mode Step Action 1 Select the Utils icon from the menu bar 2 Maintenance 7 Syringe Rod Replacement Select Continue to prepare the syringe rod assemblies for maintenance OR Select Ca...

Page 292: ...1 are now positioned for placement Figure 10 28 3 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 Unscrew the round plunger end 1 from the plunger rod adaptor 2 and remove the syringe Figure 10 29 Step Action continued 2 of 3 A015944P EPS 1 A015945P EPS 2 1 ...

Page 293: ...iscard the old plunger rod with its guide and base Note The plunger rod cannot be pulled through the brown plunger guide Figure 10 30 Step Action 1 Remove the clear sleeve from the new plunger rod tip before installing into the syringe barrel 2 Moisten the new plunger rod tip with deionized water to limit the amount of air bubbles and insert the tipped end of the plunger rod into the syringe barre...

Page 294: ...water Tap the syringe to release bubbles Screw the rounded plunger end onto the adaptor Carefully pull the syringe barrel upward until the syringe Luer lock fitting is engaged Turn the syringe barrel and lock in place 5 Select OK when all components have been replaced in the syringe assemblies NOTICE Always select OK to return the syringe plunger rods to the Home position top of the syringe unit S...

Page 295: ... Reagent and or Sample Delivery Subsystem 10 in the Number of primes to repeat field MC F4 Sample Delivery Subsystem 10 primes are already selected Select Start Prime 2 Check the syringes and aspiration lines for air bubbles If bubbles persist after priming Remove syringe and repeat Installing the Syringe Steps 4 6 and Priming the Syringes Step 1 Step Action 1 Select the Instr Cmd icon from the me...

Page 296: ...d maintenance bottle is filled with deionized water Self applied labels are included in the kit to label the contents of each bottle The maintenance bottle caps contain holes or openings into which the reagent straws from the removed reagent bottles are inserted The maintenance bottles are placed into a bottle holder and the holder is then positioned onto the bottom frame of the MC reagent compart...

Page 297: ... Using the maintenance bottles included in the MC Maintenance Kit insert the reagent straws for GLUCma BUNm UREAm ALBm and PHOSm into the container of 10 wash concentrate solution TPm and CREm into the container of 1N HCL solution Select Prime20 The cleaning solution is primed 20 times 5 When priming is complete let the solutions sit in the cups for 10 minutes 6 At the end of the 10 minute period ...

Page 298: ...y proceed to Step 13 Note Following maintenance allow 15 20 minutes for the glucose sensor to equilibrate prior to sensor calibration 13 Perform the BUNm UREAm electrode maintenance if maintenance is due at this time Refer to Monthly Maintenance Clean All Cup Modules in this chapter While the BUNm UREAm electrode is removed clean the cup and stir bar as instructed in Steps 15 and 16 If BUNm UREAm ...

Page 299: ... delicate electrode tip Using the stir bar removal tool 1 remove the stir bars from all cups not necessary for Glucose if the stir bar was previously cleaned during maintenance Clean the cups with cotton swabs moistened with deionized water Be sure to moisten the swabs before inserting them into the cups Note If the removed swab from the TPm cup is black prime TPm again with the 1N HCL solution Us...

Page 300: ...g movement Replace the stir bar if cracks or burrs are detected The larger stir bars correspond to the BUNm UREAm and GLUCm cups 18 Select OK to continue Observe whether the stir bars are turning properly CAUTION The stir bar may rise in the cup due to air accumulation in the lines Verify that the stir bar is positioned down into the bottom of the cup 19 Select Close when priming is complete to ex...

Page 301: ...cell The operator may choose to replace one or both electrode tips at the same time Step Action 1 Pour ISE Reference Solution do not dilute into a small beaker or glass container to a depth not to exceed two inches 50 mm 2 Unpack a new potassium electrode tip P N 669117 1 and or a new calcium electrode tip P N 467769 2 Unpack each tip and carefully remove the knurled protective cap 3 from membrane...

Page 302: ...ot allowed the new electrode may require a few hours of operation to achieve complete electrical stability During this period of time more frequent than normal calibration may be required in response to system error messages Assay results will not be compromised during this time Figure 10 33 4 After soaking is completed remove the tip from the soaking solution and dry sides using a lintless tissue...

Page 303: ...w cell whenever electrode removal is required Step Action 1 Loosen the two Phillips screws 1 on the ISE module cover and lift off cover Figure 10 34 2 Release the locking pin 1 on the ISE module and lift the module until it clicks The locking pin is located on the left side of the ISE module on DxC 800 Systems as shown below The locking pin is located on the right side of the ISE module on DxC 600...

Page 304: ...ting the Utils icon from the menu bar 2 Maintenance 3 ISE Service Continue The flow cell is prepared for electrode maintenance 4 Refer to the appropriate electrode procedures for servicing other electrodes As Needed As Required Maintenance Chloride Electrode or Cleaning MC Reagent Lines CO2 Measuring Electrode Cleaning MC Reagent Lines Sodium Electrode Cleaning MC Reagent Lines CAUTION To prevent ...

Page 305: ...nd calcium connector 2 Figure 10 36 2 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 Removal of the flow cell is not necessary for replacing electrodes located on the right side of the flo...

Page 306: ...ND OR Locate Calcium electrode 2 Remove electrode by turning the electrode retaining nut counterclockwise Figure 10 38 4 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 39 5 Unscrew the old tip from the electrode assembly Discard the O ring and...

Page 307: ... the appropriate terminal being careful not to bend connecting pin 11 Select OK in the Maintenance confirmation pop up window when the electrode service has been completed and the electrode has been properly replaced NOTICE Reagents will immediately prime through the flow cell While system is priming observe flow cell for leaks Stop the priming if any leaks are noticed and correct the problem 12 W...

Page 308: ...stems plugging the glucose sensor into the empty connector port labeled GLU on the BUNm UREAm module 24 hours before glucose sensor installation will minimize sensor drift Perform the following steps 24 hours prior to replacing the AccuSense glucose sensor 16 Following calcium electrode tip replacement and calibration Program and run at least 20 replicates of serum samples for CALC Recalibrate cal...

Page 309: ...port 1 of the BUNm UREAm module until the latch clicks Figure 10 40 8 Set the glucose sensor down into an empty area of the cup modules Allow the free standing sensor to remain connected but not installed for 24 hours being careful that the sensor cable is not pinched or crimped Reinstall the MC module and ISE module covers 9 Proceed to Draining Reaction Cup for Sensor Maintenance or Replacement b...

Page 310: ...con from the menu bar 2 Maintenance 4 Cup Maintenance 2 Select Glucose cup to be drained in preparation for maintenance Select Drain This will drain the cup of reagent so that maintenance may be performed OR Select Cancel to immediately return to the Maintenance Main Menu without draining the cup 3 Proceed to Sensor Replacement and Stir Bar Cleaning NOTICE When a new sensor is installed if needed ...

Page 311: ...ss the latch 1 which is located on the connector and pull out to disconnect sensor pin lead from connector panel Figure 10 41 3 Unscrew the sensor retainer nut 1 and withdraw sensor assembly from chemistry reaction cup Verify that the gasket 2 from the removed sensor has not been left in port opening Figure 10 42 4 Separate the sensor from retainer nut Discard the old sensor and gasket 1 of 3 ...

Page 312: ...p 8 Hold the new sensor connected to the BUNm UREAm connector panel in a vertical position with the membrane tip pointed downward tap side of sensor body to remove any bubbles from membrane tip 7 Note This steps applies to DxC 800 Systems only For DxC 600 Systems proceed to Step 8 Disconnect the new prepared glucose sensor from the BUNm UREAm connector panel 8 Slide the retainer nut over the cable...

Page 313: ...5 Page 10 67 10 12 Select Close when priming has completed to exit the pop up Result window 13 Select Cancel to return to the Maintenance menu 14 Reinstall the MC module and ISE module covers 15 Proceed to the Calibrate Lamps and Sensor in the Monthly Maintenance section of this chapter Step Action continued 3 of 3 ...

Page 314: ...aintenance On screen Electronic Maintenance Select F1 to access the log on the Maintenance screen Replacing the Chloride Electrode Tip Prepare the CL electrode tip as follows prior to removal and installation ISE Service Procedure The ISE service procedure prevents the flow cell from leaking reagent when an electrode is removed from the instrument Step Action 1 Unpack a new chloride electrode tip ...

Page 315: ...w cell select the Utils icon from the menu bar 2 Maintenance 3 ISE Service Continue The flow cell is prepared for electrode maintenance 4 Proceed to Replacing the Chloride Electrode below CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when performing this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this cha...

Page 316: ...his 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 Removal of the flow cell is not necessary for replacing electrodes located on the right side of the flow cell Figure 10 43 2 Locate the Chloride electrode 1 Remove electrode by turning the electrode retaining nut coun...

Page 317: ... electrode port Turn electrode retainer nut clockwise until finger tight 7 Gently pull on electrode body to test for proper seating of electrode The electrode assembly should not move If electrode moves remove it and install it again Check for an extra or missing quad ring if installation is difficult 8 Reposition flow cell on the mounting panel and tighten the one retaining screw Reconnect electr...

Page 318: ...ctrode P N 668295 10 When system has completed priming select Close to exit the procedure 11 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 12 Reinstall the ISE module cover 13 Calibrate all ISE chemistries A reference drift for new electro...

Page 319: ...pare 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 Figure 10 46 2 Unpack a new sodium electrode Carefully remove black protective cap covering glass tip 3 Soak the electrode 1 hour minimum 24 hours maximum NOTICE If maximum soaking time is not allowed the new elect...

Page 320: ... ISE Module cover and remove the cover 2 Lower the electrode face 2 into the soaking solution until only the tip is covered by the soaking solution 1 Figure 10 47 3 Release the locking pin on the left side of the ISE Module and pull up until it clicks in place Raise the module to the second locking position to extend the module to the highest point 4 Drain the flow cell by selecting Utils from the...

Page 321: ...r 2005 Page 10 75 10 6 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 Figure 10 48 7 Disconnect the electrode cable 1 Figure 10 49 Step Action continued 2 of 4 ...

Page 322: ...ptive screw 1 located the top of the flow cell Pull flow cell assembly forward Figure 10 50 9 Unscrew counterclockwise the electrode retainer nut 1 and withdraw the electrode 2 from the flow cell Verify that the quad ring from the removed electrode has not been left in port opening Figure 10 51 10 Remove the retainer nut from the old electrode and install on new electrode Step Action continued 3 o...

Page 323: ...ctrode sides and electrode port NOTICE Do not touch the electrode tip 13 Install a new quad ring 1 on the electrode Insert the sodium electrode into the flow cell Insert retainer nut 2 and turn clockwise until finger tight Figure 10 52 14 To test for proper seating of electrode gently pull on electrode body The electrode assembly should not move If the electrode moves remove it and try to install ...

Page 324: ...the Maintenance Confirmation window 2 Select Close in the Result window Step Action 1 Prime the flow cell by selecting Utils from the menu bar 1 Prime MC F4 Prime ISE ALL 2 Type 15 in the Number of primes to repeat field 3 Select Start Prime NOTICE While priming inspect flow cell for leaks If any leaks are noticed discontinue priming and correct the problem Step Action 1 CAUTION Pinching Hazard Wh...

Page 325: ...event damage due to electrical static discharge ESD wear the wrist ground strap when performing this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter Step Action 1 Loosen the two Phillips screws on the ISE module cover and remove the cover 2 Release the locking pin on the ISE module and pull up on the ISE module until it clicks into a raised po...

Page 326: ...e the CO2 measuring electrode Place absorbent tissue beneath the CO2 electrode port Using hemostats clamp off reagent Lines 33 1 and 32 2 as closely as possible to the CO2 electrode Line 32 connects as a loop to the CO2 reference electrode Remove electrode by turning the electrode retainer nut counterclockwise Figure 10 54 Step Action continued 2 of 3 ...

Page 327: ...ectrode 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 Separate the membrane retainer from the membrane clamp 2 and pull apart Discard the used membrane Figure 10 55 Step Action continued 3 of 3 ...

Page 328: ...ng 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 Figure 10 56 2 Place the membrane clamp 2 on a flat surface Using tweezers carefully center the membrane 1 on top of the membrane clamp Figure...

Page 329: ...tainer 1 over the membrane clamp 3 Press the membrane retainer into the clamp thus securing the membrane 2 Figure 10 58 4 Place the retainer assembly upside down on the work surface so the clamp is on top and retainer on the bottom Grasp the electrode carefully and press it firmly against the membrane and into the membrane clamp Figure 10 59 Step Action continued 2 of 3 ...

Page 330: ...uneven edges protruding If membrane is not centered correctly or is damaged repeat Steps 1 4 with a new membrane Figure 10 60 6 CAUTION Do not touch membrane surface when installing the quad ring Reinstall the quad ring 1 onto the membrane retainer When installed the quad ring must by on the very end of the CO2 electrode This ensures a proper fluid seal when the electrode is installed in the flow ...

Page 331: ...ve it and try to install it once again If installation is difficult check for an extra or missing quad ring 4 Reconnect tubing lines 33 and 32 to the electrode Remove hemostats Be sure the tubings fit tightly on the electrode port 5 Reconnect the electrode cable to the appropriate connector 6 Once the necessary electrode service has been completed and the electrode has been properly replaced selec...

Page 332: ... deionized water Prepare fresh Use within 24 hours 70 isopropyl alcohol 20 or 30 mL irrigation syringe CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when performing this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter Step Action 1 Loosen the two Phillips screws on the ISE module cover and remove ...

Page 333: ...e two solenoid valve cables meet For DxC 600 Systems trace the solenoid wiring to its source and disconnect Pull apart the valve connector to disconnect Figure 10 62 4 Carefully remove the Phillips screw and washer 1 screw removed in figure located on the top of the EIC Lift off the EIC two sections with solenoid valves 2 attached from the drip tray 3 NOTICE DO NOT REMOVE the two screws on the dri...

Page 334: ...sue 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 6 Carefully loosen the two screws 1 from the solenoid valve located on the back side of the EIC Remove the solenoid valve and set aside Figure 10 65 Step Action continued 3 of 7 ...

Page 335: ... Flush the 10 bleach solution through the valve port This flushes the sample inject area Allow the bleach solution to sit for 1 minute Note The 1 minute waiting period applies only to the 10 bleach solution and not to the following deionized water or 70 isopropyl alcohol 9 Repeat the flushing procedure through the valve port using deionized water 10 Repeat the flushing procedure through the valve ...

Page 336: ... sit for 1 minute Note The 1 minute waiting period applies only to the 10 bleach solution and not to the following deionized water or 70 isopropyl alcohol 14 Repeat the flushing procedure through the flow cell exit port using deionized water 15 Repeat the flushing procedure through the flow cell exit port using 70 isopropyl alcohol 16 Repeat the flushing procedure through the flow cell exit port u...

Page 337: ...re 10 68 19 Reattach lines 18 24 23 26 and 15 to the EIC ports Refer to Figure 10 64 20 Remove clamps from lines 18 24 23 and 26 21 Reattach the EIC top sections to the drip tray Align the guide pin on the bottom of the EIC to the hole on the drip tray and press the EIC down onto drip tray Tighten the Phillips screw on the top of the EIC 22 Reconnect the solenoid valves at the valve connector 23 S...

Page 338: ... the ISE module cover 27 Calibrate the ISE chemistries Step Action continued 7 of 7 DO NOT use Ultra Bleach Advantage CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when performing this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter Step Action 1 Loosen the two Phillips screws from the ISE module ...

Page 339: ...les to finish 8 Remove the alkaline buffer reagent straw from the deionized water and dry the straw with lintless tissue 9 Reinstall the alkaline buffer reagent cap and straw onto a new bottle of alkaline buffer reagent 10 Prime the ISE CO2 Alkaline Buffer 15 times by selecting the ISE CO2 Alkaline Buffer check box Type 15 in the Number of primes to repeat field Select Start Prime Wait for prime c...

Page 340: ... reinstall the ISE module cover 15 Calibrate CO2 chemistry Step Action continued 3 of 3 CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when performing this procedure For further instructions refer to Basic Laboratory Practice at the beginning of this chapter Step Action 1 Loosen the two Phillips screws on the ISE module cover and remove the cover 2 Rel...

Page 341: ... 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 5 Carefully set aside the drain top with tubing 22 attached 6 Remove the drain tube 1 from the drain Figure 10 70 7 Using four to five cotton swabs soaked with deionized water clean the inside of the lower drain and the top of drain Step Action continued 2 ...

Page 342: ... lintless tissue soaked with deionized water Thoroughly wipe dry the ISE drain 10 NOTICE Do not pinch damage or disconnect the adjacent connector wires while reinstalling the drain top Reinstall the ISE drain top onto the drain Align the two posts extending from the bottom of the drain top with the holes in the acrylic drain mount and gently lower the drain top until it sits flush with no gaps on ...

Page 343: ...20 mL syringe hemostat CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when performing this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter Step Action 1 Remove ISE module cover and raise the ISE module to a locked position 2 Prepare for ISE Maintenance and disable autoprime by selecting the Utils i...

Page 344: ...stat remove line 35 from the top of the flow cell Remove line 27 from the front of the flow cell in order to allow residual acid to leak out 6 Draw back on the syringe This will withdraw any remaining solution left in the flow cell and remove any material that may be causing the occlusion of the small lumen Note The procedure may be concluded here if the problem has been resolved Proceed to Step 9...

Page 345: ... 72 9 Reattach the lines to the flow cell and remove the hemostat 10 Once all components are in place for the flow cell select OK to prime the flow cell Select Close in the pop up window to exit the ISE Service screen 11 Prime the flow cell 5 times by selecting the Utils icon from the menu bar 1 Prime MC F4 ISE All check box Type 5 in the Number of primes to repeat field Select Start Prime 12 CAUT...

Page 346: ...y due to inaccurate calibrations As instructed by Hotline or Service Engineer A calibration of ALL flow cell chemistries is required after completion of the cleaning procedure Material Required Diluted Clenz Solution freshly prepared by adding 10 drops of Clenz Solution Concentrate P N 664090 to 5 mL Saline One 5 mL syringe Flow cell cleaning kit P N 473181 optional Completely fill the syringe wit...

Page 347: ... cell Be sure that liquid completely fills the flow cell and that there are no air bubbles in the line DO NOT REMOVE SYRINGE FROM THE LINE 6 Allow the system to stand idle for 5 minutes DO NOT REMOVE SYRINGE FROM THE LINE DURING THIS TIME 7 Push on the syringe plunger to completely remove the Clenz Solution from the flow cell 8 Use back and forth plunger motion to scrub the flow cell with air 9 Di...

Page 348: ...MC F4 ISE ALL check box Type 20 in the Number of primes to repeat field Select Start Prime 15 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 tubing as the flow cell module is lowered 16 Reinstall the ISE module cover 17 Calibrate all ISE chemistries twice Run controls to verify I...

Page 349: ...sembly to the top of the probe assembly where the fitting for the probe tubing was removed in Step 3 Tighten no more than finger tight 5 Fill a 10 mL syringe with diluted cleaning solution or other recommended wash solution Connect the syringe to the other end of the probe cleaning assembly 6 Dispense all of the syringe contents through the probe into the collection cup Repeat until 50 mL has been...

Page 350: ...should be replaced when visual inspection or chemistry performance indicates there is a compromised probe condition scratches pits or blockage These instructions cover installation of the replaceable style probe To remove the old probe follow the steps below CAUTION To prevent damage due to electrical static discharge ESD wear a wrist ground strap when performing this procedure For further instruc...

Page 351: ...lock with the threaded end upward 2 Install a new O ring in the groove on the tip of the nut It is OK to reuse an old O ring if the new o ring is lost 3 Slip the probe up into the level sense bead fitting being careful not to lose the O ring 4 Tighten the probe with a wrench until it makes solid contact and locks within the fitting 5 Wipe the outside and bottom portion of the probe with 70 isoprop...

Page 352: ... the current probe is re installed after inspection without moving the bead assembly no alignments required a new MC Sample Probe is installed MC Sample Probe Vertical Home and Wash MC Sample Probe Sample Height MC Sample Probe Cup Height MC Sample Probe EIC Height a new CC Sample Probe is installed CC Sample Probe Vertical Home and Wash CC Sample Probe Cuvette Height CC Sample Probe Sample Height...

Page 353: ...ormance Once the probe installation is complete run controls to confirm proper instrument performance If the controls are out but no leaks are seen recalibrate all chemistries and rerun controls 1 Sample Probe 2 Collar Wash 3 Waste Port 4 Wash Port 5 Probe tip is even to the bottom edge of the wash port 1 Reagent Probe 2 Collar Wash 3 Waste Port 4 Wash Port 5 Probe tip is even to the middle of the...

Page 354: ...selecting the Rgts Cal icon from the menu bar An empty chem position to load CC side Load F1 Scan Chemistry Wash Solution Cartridge CCWA 2 The Wash procedure is accessed by selecting the Utils icon from the menu bar 2 Maintenance 2 Cartridge Chemistry Probe Cleaning OR Type 2 in the Procedure No field and press Enter Follow all instructions listed on the screen 3 Select Cancel to exit this screen ...

Page 355: ...lar wash assembly is causing increased level sense errors Material Required One sample rack One 2 mL cup Undiluted household bleach Sodium hypochlorite 5 25 5 Exit the Maintenance menu NOTICE To resume autoprime and return the system to Standby you must exit the Maintenance menu 6 Remove the CCWA cleaning solution cartridge Recap the cartridge and store at room temperature Reuse at the next mainte...

Page 356: ...compromised testing should be OK Ignore the values shown in the fluid level column 5 Allow the test to continue until 10 to 12 data points are shown in the fluid level column The MC sample probe has aspirated approximately12 times Select Stop to end the testing The test rack will automatically unload 6 Select Close to exit the screen Then select Exit to leave the Diagnostic screen 7 Select the Uti...

Page 357: ...oating at the top of the PHOSm cup surface 2 Drain the PHOSm cup by selecting the Utils icon from the menu bar 2 Maintenance 4 Cup Maintenance Phosphorus button Drain The cup drains in preparation for maintenance 3 Clean the inside of the PHOSm cup with an applicator swab moistened with deionized water 4 Select OK when the cup cleaning is complete The cup will prime 5 times with water 5 Select Clo...

Page 358: ...r a local Beckman Coulter Representative to identify and resolve any suspected problems Step Action 1 Remove the Cuvette Wash Station cover Pull up on the two locking pins Move the right side of the cover forward Carefully lift out the cover without disturbing the CC Sample Mixer 2 Remove the two thumbscrews 1 on each side of the cuvette washer and lift off the upper section of the cuvette wash as...

Page 359: ...y be used to remove blockage by blowing air through probes from the probe top If the blockage cannot be removed call the Clinical Support Center for further assistance and for instructions on how to replace cuvette washer probes 7 Place each of the first three wash probes into three 13 100 mm test tubes one probe per test tube Be careful to keep the probes above the surface of the liquid 8 Prime t...

Page 360: ...tainers This will restrict the vacuum 10 Prime the wash lines once by selecting CC F2 Cuvette wash Type 1 in the Number of primes to repeat field Select Start Prime Observe the cups at the end of the prime cycle This step is performed to ensure that the contents of the cuvettes are being completely evacuated at the end of each cleaning step Therefore there should be no liquid remaining at the end ...

Page 361: ...ted on the screen 2 Select Continue to perform the procedure If desired you may exit this procedure at any time before it is completed by selecting STOP on the instrument wait for system to finish processing OK to clear pop up message Cancel to exit the procedure screen the Instr Cmd icon from the menu bar 1 Home 3 Select Close at the completion of this procedure to exit the pop up Result window 4...

Page 362: ...e procedure or when a procedure is aborted exit Maintenance menu to resume autoprime Return the system to Standby Step Action 1 Load the CCWA cartridge onto the system by selecting the Rgts Cal icon from the menu bar An empty chem position to load Load F1 2 This procedure is accessed by selecting the Utils icon from the menu bar 2 Maintenance 9 CC Reagent Wash All Cuvettes or Type 9 in the Procedu...

Page 363: ... continued 2 of 2 Step Action 1 Remove reaction carousel cover 1 and sample carousel cover 2 Figure 10 78 2 Use a good grade of disinfectant soap and a soft brush scrub covers 3 Rinse covers in deionized water Dry thoroughly using lintless tissue 4 Reinstall covers 5 Wipe all exposed surfaces on the system including sample rack area covers pull down cover compartment doors keyboard table surfaces ...

Page 364: ...s 2 Using a large container or sink immerse all sample racks in the bleach solution 3 Allow the sample racks to soak at room temperature in the 10 bleach solution for 15 20 minutes 4 Remove the racks rinse with deionized water or tap water and allow to dry NOTICE Repeated decontamination of racks may result in rack label damage If the label starts to bubble or peel remove and replace with a new la...

Page 365: ...le compartment door release latch 1 on the hydropneumatics drawer and pull out the hydropneumatic system Figure 10 79 3 Remove the Wash Concentrate bottle 1 the DI Water Reservoir canister 2 and the DI Water canister 3 from the system If necessary use the spanner wrench tool to remove the canisters Figure 10 80 Step Action continued 2 of 3 A016466P EPS 1 A016489P EPS 1 2 3 ...

Page 366: ...ect the Utils icon from the menu bar Select Prime Select the All CC Subsystems check box Type 10 in the Number of primes to repeat field Select MC F4 Select the following check boxes Sample Delivery Subsystem EIC wash DI water All cup chemistries ALBm CREm GLUCm PHOS TPm BUNm UREAm Select Start Prime Allow all primes to complete 9 Repeat Steps 1 8 three more times 10 After the last prime is comple...

Page 367: ...ay cause a contaminated condition As a result use this procedure to replace the wick as needed Materials Required Collect the following materials 1 medium flat edge screwdriver 1 medium Phillips screwdriver for DxC 600i systems 1 small tweezers 2 plastic trays approximately 9 inches 12 inches 23 9 centimeters 30 5 centimeters Absorbant paper towel 1 bottle of Auto Gloss 1 Wick Kit P N A26924 Cotto...

Page 368: ... 10 81 and perform the following steps Step Action 1 Select the Utils icon from Main menu bar 2 Select 2 Maintenance 3 Select 1 1 Blade Thick CTS Blade Replacement 4 Select Continue Wait for the Maintenance Confirmation screen CAUTION DO NOT select OK on the screen when the cover is removed This would move the Cap Piercer upward and cause a pinching hazard Step Action 1 Lift the instrument cover 2...

Page 369: ...embly is now visible as shown in Figure 10 82 Remove the Blade Assembly and Wick Clip Assembly as follows Step Action 1 Refer to Figure 10 82 Use a flat head screwdriver to loosen the two Blade Holder Screws 1 from Blade Holder 2 CAUTION The points of the Blade 3 are very sharp and extend below the Wash Tower 4 To prevent possible injury or exposure stay away from the bottom of the Wash Tower Figu...

Page 370: ...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 To prevent possible injury or exposure avoid the Blade area Figure 10 83 3 Put the Blade Assembly onto a plastic tray DO NOT touch the Blade Step Action 2 of 3 A007558P EPS 1 ...

Page 371: ... Clip as shown in Figure 10 84 Make sure that the old Wick is retained within the Wick Clip If the wick is NOT in the Wick Clip the Wick should be found within the Wash Tower area In this case use tweezers to remove the Wick Put the old Wick and Wick Clip into a biohazard waste container CAUTION Observe all laboratory practices or procedures that pertain to handling of infectious and pathogenic ma...

Page 372: ... the instrument If required use the tray to carry blade wick items to other locations Clean the Blade as follows Step Action 1 Refer to Figure 10 85 Rinse the Blade with hot water 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 Figure 10 85 1 of 2 A007560P EPS ...

Page 373: ...fer 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 Figure 10 86 3 Put the Blade Assembly back on the same tray Step Action 2 of 2 A007561P EPS ...

Page 374: ...87 during the following steps Step Action 1 Remove a new Wick Clip Assembly includes wick clip and wick from package 2 Put a piece of paper towel onto another tray Put the new Wick Clip Assembly onto the paper towel 3 Use a pipette and apply10 to 12 drops of Auto Gloss Lubricant 1 directly onto the Wick 2 or apply the drops until the Wick becomes saturated CAUTION Be careful when handling Auto Glo...

Page 375: ...ry or exposure avoid the Blade area 3 Lift up the Blade Assembly again as shown in Figure 10 83 Put the Blade Assembly back on the plastic tray 4 Remove the Wick Clip Assembly again as shown in Figure 10 84 Examine the bottom of Wick area for any loose fibers Remove any loose fibers with scissors Note Loose fibers will clog the drain 5 Repeat Steps 1 and 2 above 6 Align Blade Holder 2 to screw hol...

Page 376: ...600i system loosen the two Phillips screws on the cover of the DxC Load Area and remove the cover Place the rack into the DxC Load Area with no sample programming Note Do not load the rack into the DxC 600i Load Area Loosen the screw and open the cover of the DxC Load Area RUN button located to the right of the DxC 600i Load Area Press the DxC Load Area RUN button to pierce the tube caps Inspect t...

Page 377: ...or Use A13914 System Status and Commands October 2005 Page 11 1 11 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 ...

Page 378: ...ion exists on the Status Monitor Screen A highlighted status icon should be investigated by the operator as further action may be necessary to correct the warning or error condition Step Action 1 Select the Status icon from the menu bar 2 A summary of the monitored areas appears Table 11 1 Status Messages Status Description Error Parameters which exceed allowable limits are called errors If any of...

Page 379: ...n 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 Returning to Status Summary When viewing the detailed status information it is possible to return to the Status Summary by selecting Summary F1 ...

Page 380: ...ular Chem Each result for each cup is counted separately Even if ORDAC is triggered the counter only increments for the one result ISE A count of the number of samples run through the ISE module Whether it is a single chemistry per sample or a sample running all five chemistries the ISE cycle count will increment only once per sample processed through the ISE module Cartridge Chem Each cartridge c...

Page 381: ...aying Temperature Status Follow the steps below to monitor instrument components e g reaction carousel cups cuvette wash NOTICE While the system is in the Stop state temperatures will not be accurate If the system boots directly into the Stopped state no temperatures will be shown for the systems that caused the Stop state If the system goes to Stopped from Standby or Running the temperatures show...

Page 382: ...id 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 A red highlight indicates an error condition Also shown is the status of the eight power supplies OK Warning or Error with the same highlight colors Displaying Power Subsystem Status Step Action 1 Select the Status icon from the menu bar 2 ...

Page 383: ...er is Out of Limits The range for air and vacuum levels are only valid when the system is in Standby and the hydropneumatics are on The hydropneumatics are automatically turned off after the system has been in Standby for more than 15 minutes While the hydro is off all pressure and vacuum readings will show zero and a status of OK To turn the hydro back on either select a prime or press the RUN bu...

Page 384: ...rom 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 A yellow highlight indicates a warning condition and a red highlight indicates an error condition Step Action 1 Select the Status icon from the menu bar...

Page 385: ...e lost when the system is reset or powered off Once absorbance values have been lost the absorbance value will be zero 0 until a water blank test has been run Displaying Cuvette Water Blank Status If any of the absorbances are out of limit the cuvette number is highlighted in red indicating the cuvette has been marked as dirty and will not be used for analysis The right most column is the Failed C...

Page 386: ...d be sure that its sample ID has not been cleared If you clear a sample ID at the Host the sample ID is NOT cleared in the CTS Tracking database If you were to manually clear the sample ID for a tube you would also clear the sample ID in the CTS Tracking database The instrument would think it has a new tube and would pierce its cap again For each DxC instrument in the network CTS Tracking status s...

Page 387: ...commands are available Home moves all mechanical assemblies to a known position Pause stops additional tests from starting any tests with reagent already added will complete Stop Print prevents print requests in the queue from being sent to the printer Shutdown reboots the system warm boot or safely powers off the system Pause Waste B allows the external Waste B container to be emptied while the s...

Page 388: ... the instrument MC or CC is Stopped and the other side is running the Home command operates on the side that is Stopped The other side of the instrument continues to run NOTICE If the STOP button is pressed immediately after selecting Home Wait at least 10 seconds Press the STOP button again This makes sure that the system correctly reaches the Stopped state Step Action 1 Select the Instr Cmd icon...

Page 389: ...ing stops as soon as the last result is available Cuvettes may be left dirty When to Use Pause Use Pause when the system must be interrupted but there is not an immediate need to stop the samples in process Correct uses of Pause include when maintenance is needed but the system is already running when a rack needs to be removed from the sample carousel but is not needed immediately or to avoid was...

Page 390: ...f the reagent load the system will resume running samples Sample on the sample carousel is needed immediately from the Main screen select the rack with the sample needed and select Unload F2 Note that any tests that have been started for the samples in the rack that have not yet had sample added will be aborted The rack however will be available within approximately 40 seconds Step Action 1 Select...

Page 391: ...es such as the entire Event Log some QC reports or preventing multiple print requests How Stop Print Works Print requests are stored in the printer queue in the console As portions of these requests are ready to print they are sent to the printer buffer and ultimately print Stop Print deletes all of the print requests in the queue Any portions of the print request already in the printer buffer whi...

Page 392: ...appears on the monitor If power is turned off before this there is a potential for data corruption Step Action 1 Verify that the system is in Standby or Stopped 2 Select the Instr Cmd icon from the menu bar 3 Select 4 Shutdown OR Type 4 in the Command No field and press Enter 4 Select OK or Cancel If OK is selected the Shutdown in Progress screen appears with the message Please wait for further in...

Page 393: ...mponents of the system DC Output Power Supplies Power is routed to redundant DC output power supplies which provide 24V or 36V power for distribution throughout the system By using redundant power supplies not all are used at any one particular time Should one fail the operator is alerted but may continue operation unaffected Uninterruptible Power Supply UPS The computer console requires an additi...

Page 394: ...1 18 October 2005 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: ... MSMC Boot follows the ICC Boot Again a bar graph shows progress The next area booted is the Smart Module Boot a bar graph shows progress The final step includes homing of all mechanisms removal of any racks on the sample carousel and priming of the system Upon completion of the boot sequence the instrument status shown on the console changes to Standby Following Boot up If a temperature error occ...

Page 396: ... Power On Boot Reset System Status and Commands UniCel DxC Systems Instructions For Use A13914 Page 11 20 October 2005 Reset For instructions on performing a reset or reboot refer to Shutdown in this chapter ...

Page 397: ...o normal operation after Waste B removal has been paused or to recover from certain flood conditions How to Pause Waste B Waste B removal will be paused until Resume Waste B is selected The Instrument Commands screen remains so that Resume may be selected Pause Waste B will be gray to indicate it is already paused How to Resume Waste B The system will return to its normal operational state The Ins...

Page 398: ...le should be enabled or disabled only when the system is in Standby or is Stopped To complete the enable for 1 Blade thick CTS or LPIA the operator must stop and home the DxC All programming for Disabled modules is aborted Modules or subsystems in the Disable mode will not run prime or perform desired maintenance diagnostic procedures When the MC module is enabled the related reagent is primed 4 t...

Page 399: ...K to confirm Modules shown in the message box OR Select Cancel to exit without saving changes NOTICE After enabling a chemistry or a module run controls to make sure of proper operation If a reagent is loaded while the module is disabled prime the module eight times after the module has been enabled Starting from a Stopped state a module is not enabled until the system is homed and goes to Standby...

Page 400: ...to the offload track It can be used when access to a sample is required or after a system error if a rack is shown on the Main Screen but it is not physically on the carousel Unloading All Racks Step Action 1 Select the Instr Cmd icon from the menu bar 2 Select 8 Unload All OR Type 8 in the Command Number field and press Enter 3 All racks on the sample carousel are removed and the Instrument Comma...

Page 401: ...rview 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: ...e Cuvette Wash Station Primes cuvette wash Probes 1 and 2 with wash and Probe 3 with water Table 12 2 A Prime for the Hydropneumatics Subsystem Hydropneumatics Subsystem Function Fill canisters and reservoirs Fills water wash and diluted wash CC Drain waste sump Drains waste sump and exit sump CC Drain Waste B sump Drains Waste B sump and exit sump Drain gravity drain sump Drains the gravity sump ...

Page 403: ... Subsystems Function ISE Module all Primes all reagents used by the ISE module Electrolyte Buffer Primes the CO2 electrodes with Alkaline Buffer Reagent Electrolyte Reference Primes both Electrolyte Reference and CO2 Acid Reagent EIC Wash Primes Electrolyte Buffer Reagent ISE CO2 Alkaline Buffer Primes Electrolyte Reference Reagent Reference and Acid Primes DI water to the EIC Sample Delivery Subs...

Page 404: ... the Utilities dialog box select 1 Prime OR Type 1 in the Option Number field and press Enter 2 Select one or a combination of the following check boxes All CC Subsystems All Hydropneumatic Subsystems All MC Subsystems Prime DxC CTS Auto Gloss CTS System only CTS Blade Wash CTS System only 3 Type the desired number of primes 1 99 in the Number of primes to repeat field This does not apply for Hydr...

Page 405: ...owing check boxes Reagent Delivery Subsystem Sample Delivery Subsystem Cuvette Wash 4 Type the desired number of primes 1 99 in the Number of primes to repeat field 5 Select Start Prime The system status changes to Priming and the number of primes remaining are shown 6 Upon completion of the requested prime the number of primes remaining will be blank and the system status returns to Standby Step ...

Page 406: ... only option Only one ISE selection can be made at a time However the ISE All option can be used to select the entire list Follow the steps below to prime the MC Subsystems Step Action 1 From the Utilities dialog box select 1 Prime OR Type 1 in the Option Number field and press Enter 2 Select MC F4 3 Select the desired cup s and specify Reagent and or DI water AND OR Select a single ISE option by ...

Page 407: ... Page 12 7 12 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 ...

Page 408: ...ntire Event Log can be viewed printed or copied to disk It is possible to select only a portion of the Event Log to work with by specifying classes and or a date and time range Event Log Classes Table 12 6 Event Log Classes Class Number Event Log of entries 1 Chemistry Errors 10 000 2 Motion Errors 10 000 3 Status Monitor Errors 10 000 4 Other Instrument Errors 10 000 5 Instrument Events 120 000 6...

Page 409: ...nd Seconds Description Identifies the event or error that occurred Step Action 1 Select the Utils icon from the menu bar 2 Select 3 Event Log OR Type 3 in the Option Number field and press Enter 3 Select the desired Classes If no Classes are specified all classes in the Event Log will be retrieved 4 Select Display to view the status of the desired event Table 12 8 Event Classes Information Options...

Page 410: ...y that only the desired event classes for the appropriate time period are selected Done To exit Table 12 8 Event Classes Information Options continued Option Description 2 of 2 Step Action 1 Select the Event Log classes and a date time range if desired 2 Select Display from the Event Log Screen 3 To transfer information to diskette select Copy to Disk from the Display Events dialog box AND follow ...

Page 411: ...time range if desired 2 Select Copy from the Event Log Screen OR Select Copy to Disk from the Display Events dialog box 3 Insert an MS DOS formatted diskette into the floppy disk drive 4 Select OK to transfer information to a diskette OR Select Cancel to return to the Display Events dialog box without copying the information 5 While the transfer is occurring Copying to Disk Please Wait appears Not...

Page 412: ...ate and time period Clearing Events The Clear option is used to remove unwanted event information It removes all events in the selected classes even if a date time range has been entered If no classes are specified the entire Event Log is cleared Step Action 1 Select Time from the Event Log Screen 2 Type in desired time period Press the Tab key to advance the cursor to each field 3 Select OK to ac...

Page 413: ...om the Event Log screen Print always sends the complete selection to the printer If a print of the current page screen is required use Print Scrn from the keyboard NOTICE Use the Print function carefully when in the Event Log Because there is a maximum of 100 000 events printing the entire Event Log will take several minutes and many pages of paper to complete the report Step Action 1 Select the d...

Page 414: ...ignment 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: ... 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: ...em 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: ...n of a new software version a change in alignments or a change in system parameters especially setup parameters To perform a backup follow the steps below Note Alignment files are on a separate diskette from System Parameters Depending on the instrument configuration System Parameters may require more than one diskette NOTICE Do not start a backup of System Parameters or Alignments while the print...

Page 418: ...t before copying data 6 Select OK 7 The diskette is then formatted and the backup files are created 8 When the backup is complete a confirmation appears on the screen Select OK 9 Remove the diskette and label it with the following information date of backup type of backup System Parameters or Alignment Data current software and chemistry database version instrument serial number If both System Par...

Page 419: ...iskette into the floppy disk drive If both System Parameters and Alignment Data Files are selected insert the Alignment diskette first 5 Select OK The date the backup was performed type of backup instrument serial number database version and chemistry database version will be shown 6 Select OK A warning message appears indicating that all host communication Database and Print functions will be dis...

Page 420: ...pparently changes its position when seen from different angles side top or front Therefore before the calibration install the monitor in a stable position at eye level if possible Procedure Calibrate the touch screen in the same position sit or stand as most operators work Follow the steps below to calibrate the touch screen Step Action 1 Select the Utils icon from menu bar 2 From the Utilities di...

Page 421: ...t The flags may be indicative of a variety of different hardware reagent or sample calibrator issues and can be used to troubleshoot different system issues Any calibrator or sample outside of any one or more calibration limits will be flagged Calibration Error Flags Table 13 1 below is a general list of the calibration errors for linear multipoint and MC calibrations These errors are listed in th...

Page 422: ...ange low RECOVERY Calibration failed Recovery error SENSITIVITY Calibration failed Sensitivity error SEV RECOVERY Calibration required Severe recovery error SEV SENSITVITY Calibration required Severe sensitivity error SPAN Calibration failed Sensitivity error RANGE Calibration failed Accuracy error ISE Table 13 1 Calibration Error and Remarks continued Printed Flag Remarks on Report Description 2 ...

Page 423: ...ration A back to back value is the difference between the two middle Sample Reference replicate values within a calibration level If the back to back limit is exceeded the calibration fails Only the two replicates that meet back to back are used all other replicates are discarded Select Calibrator Acceptance Limits under Options in the Rgts Cal screen to view current calibration limits Calibrator ...

Page 424: ... is a measure of sensitivity and verifies that two consecutive calibrator level ADC values are a minimum distance apart The difference between the average ADC value of Calibrator 1 and the average ADC value of Calibrator 2 or between the average ADC value of Calibrator 2 and the average ADC value of Calibrator 3 must exceed the minimum span limit Select Calibrator Acceptance Limits under Options i...

Page 425: ...rage of eight readings The ADC difference between the minimum and maximum readings must be less than the predefined limits a noise flag will occur This does not apply to CO2 Reference The average of the eight ADC readings corresponding to the measurement of the Electrolyte Reference Solution For CO2 the reference ADC represents the rate of pH change initiated by the reference reagent Reference Dev...

Page 426: ...se errors that FAIL the calibration will print Table 13 5 Cup Module Calibration Report Field Definitions Field Description Rate Represents the rate of change in ADCs during the reaction Rate is used for back to back span and range checks Initial Read Represents the conductance measured by the electrode or absorbance measured by detector with only reagent present in the cup Final Read Represents t...

Page 427: ...ate with any of the asterisked fields listed within the calibration report This section of the report appears only when a calibration fails Reagent Identifies the failed chemistry Level Identifies the calibrator level which failed Condition In the event that an error occurs an asterisk appears next to the value which is out of specification The corresponding error flag will print in this field Onl...

Page 428: ...quations refer to CHAPTER 2 System Description Endpoint and First Order Chemistries and Endpoint and First Order Calibration Formulas Calibration flags that are specific to the linear photometric chemistries causing the reagent to fail its calibration are back to back and Calibrator Range High Low errors and for linear chemistries that use more than one calibrator Span To view the calibration flag...

Page 429: ...hich chemistry is being calibrated Units Selected units shown for reference S N Specifies the serial number of the reagent cartridge being calibrated Lot Identifies the lot number of the specific cartridge Loc Identifies the location of the reagent cartridge on the reagent carousel Cuv The cuvette number on the reaction carousel in which the reaction took place Set Points The target value for the ...

Page 430: ...ent Identifies the failed chemistry Lot Number Identifies the lot number of the reagent which failed calibration Serial Number S N Identifies the serial number of the specific cartridge which failed Cuvette Identifies the cuvette in which the specific replicate failed Condition In the event that an error occurs an asterisk appears next to the value which is out of specification The corresponding e...

Page 431: ...05 Page 13 11 13 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 absolute delta OCR absolute delta All others no magnitude Table 13 6 CC Linear Calibration Report Field Descriptions continued Field Description 3 of 3 ...

Page 432: ...ar Chemistries and Non Linear Calibration Formulas for additional information on this subject Non Linear Calibration Checks Non linear calibrations have a set of calibration checks specific to non linear calibrations The first check determines whether the data is reasonable to attempt the curve fitting The second check determines whether the Multipoint span is within acceptable limits The next set...

Page 433: ...a non overrideable extreme recovery error Refer to RECOVERY error Sensitivity Sensitivity is a check of the calibration slope for each calibrator level and several intermediate levels to check if the response is too high or low This error is overrideable Severe Sensitivity Severe Sensitivity is a non overrideable extreme sensitivity error Refer to SENSITIVITY error Math Errors These errors occur w...

Page 434: ... on the reagent carousel Math Model Identifies the specific Math Model used to calculate the curve parameters Cuv The cuvette number on the reaction carousel in which the reaction took place Level The level of calibrator being run Set Points The target concentration value for the calibrator level Blank The reagent blank absorbance when it is an ENDPOINT chemistry or the reagent blank rate absorban...

Page 435: ...e reagent which failed calibration Serial Number S N Identifies the serial number of the specific cartridge which failed Cuvette Identifies the cuvette in which the specific replicate failed Condition In the event that an error occurred an asterisk appears next to the value which is out of specification The corresponding error flag will be printed in this field Only those errors that FAIL the cali...

Page 436: ...e 13 16 October 2005 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 SPAN absolute delta All others no magnitude Table 13 7 Non Linear Single Point and Multipoint Calibration Reports Field Definitions continued Field Description 3 of 3 ...

Page 437: ...Table 13 8 below Table 13 8 Error Type and Description Error Type Description Error appeared in Result Column on report Indicates a result issue result condition or suppressed result Error condition appeared in Remarks column on report Indicates the reason for suppressed results or a condition associated with the result like reference ranges Host Code Host codes are transmitted to the host with th...

Page 438: ...t Printed V Rerun result Result Printed O ORDAC result Result Printed P Default Panel Result Printed OK Calculation completed Result Printed CRITICAL HIGH Exceeds Critical range high Result Printed CRITICAL LOW Exceeds Critical range low Result Printed HIGH Exceeds reference range high Result Printed LOW Exceeds reference range low Result Printed TEMP ERR TM T Temperature error X X lower inst rang...

Page 439: ...NG TEST Not ready PROBE OBSTRUCT Probe obstruction detected RACK CONFLICT HDLC IBCT HbA1c sample in wrong rack test cancelled RESULT ERROR Result error Results Suppressed AG EXCESS AX Antigen excess Results Suppressed BL ABS HI BH Blank absorbance high Results Suppressed BL ABS LO BL Blank absorbance low Results Suppressed BL MAX DEV BO Blank outlier maximum deviation Results Suppressed BL MEAN DE...

Page 440: ...e high Results Suppressed ORR LO UL Out of reportable range low Results Suppressed ORR O HI UO Out of ORDAC reportable range high Results Suppressed OVERFLOW OF Number overflow error Results Suppressed REF NOISE DR Reference signal noise ISE only Results Suppressed RX ABS HI HR Reaction absorbance high Results Suppressed RX ABS LO LR Reaction absorbance low Results Suppressed RX ERR RE Reaction er...

Page 441: ...e Mean Deviation The average difference between the absorbance readings and the line of regression is greater than allowed This is a check for a constant rate during the blank spin cycle The flag may indicate possible issues with a photometer reading Blank Outlier Maximum Deviation A single blank absorbance data point obtained during the reagent blank read window deviates more than allowed from th...

Page 442: ...ted tests Chemistry Not Run Chemistry not run for non specified reason Reload sample and attempt to run again Division Error Special Calculation had a zero 0 result in the denominator of the calculation Check results for the test in question and rerun test if necessary Erratic ADCs The erratic ADC flag is an indication of MC cup noise Noise is determined differently within each cup dependent on ea...

Page 443: ... this manual for additional information A faulty calcium electrode MAY also cause sample reference drift errors on sodium and potassium results Excessive Reference Drift Sample to Sample The reference ADC value for a sample drifted above the acceptable difference between consecutive samples The units are measured in ADCs and are a measurement of reference reagent readings by sample electrode This ...

Page 444: ...r sample or the trigger reagent inject exceeds specifications This flag is used to trigger auto and manual ORDAC testing For the MC chemistries GLUCm BUNm UREAm TPm not CSF and ALBm this flag indicates a failure in the related stirrer mechanism Insufficient Diluent Reagent The Diluent cartridge currently loaded on the system does not contain adequate volume of reagent to perform all required on bo...

Page 445: ...ll receives a level sense error refer to the UniCel DxC Synchron Clinical Systems Reference Manual CHAPTER 5 Advanced Troubleshooting CC Hardware Symptoms for additional investigation Low Sample Fluid No sample detect MC Reagent Level High Low Reagent level detected with cup is either too high or too low A high flag may indicate issues with a blocked drain value low vacuum or malfunctioning level ...

Page 446: ... range high Refer to Reportable Ranges Setup in CHAPTER 4 System Setup Options in this manual for additional information Out of Reportable Range High Low Result exceeds the operator defined reportable range high or low Refer to Reportable Ranges Setup in CHAPTER 4 System Setup Options in this manual for additional information Probe Obstruction Detected The system detected a block in the sampling s...

Page 447: ...asured in delta absorbance minute If a high flag is triggered dilute the sample and rerun If a low flag is triggered rerun sample for verification The low flag may also indicate an old or contaminated reagent cartridge It is not appropriate to report a result of or the analytical range of the analyte for this error code Reagent Days Exceeded On board reagent has exceeded the usable days The result...

Page 448: ...Technical Support for additional information Sample in Wrong Rack The requested tests have been programmed in the wrong rack when pre programmed reserved racks have been specified for requested tests Refer to Reserved Racks Obstruct Detect in CHAPTER 4 System Setup Options in this manual for additional information on reserved racks Sample Signal Noise The difference between the high and low values...

Page 449: ... 1 which is outermost CAU Align Sample rack positions are in reversed order Message ID 0x01F80019 Description Wrong order used for rack positions while performing alignment Redo the alignment making sure the correct positions are used position 1 is on the outside of the sample carousel 0x01F90005 3 Reagent Carousel Temperature Error Reagent Stability may be compromised CAU Reagent Carousel Tempera...

Page 450: ...p float switch has indicated that the canister is full which is considered a flood for this canister Check the waste collection sump canister for liquid Empty if necessary Press the STOP button and HOME the system Contact Beckman Coulter Technical Support Center for additional information 0x01FA0006 4 Flood In Primary Vacuum Accumulator Switch 22 CAU Flood In Primary Vacuum Accumulator Message ID ...

Page 451: ... All CAU DI Water Canister Is Not Filling At All Message ID 0x01FA0009 Description Whenever the DI water canister does not fill within its given amount of time it will time out and flag that it has not filled Make sure DI water is turned on at the source and present in the DI Water Reservoir If Reservoir is full press the STOP button and HOME the system If the error continues contact Beckman Coult...

Page 452: ...tle Are Full Message ID 0x01FA0014 Description Both The Waste B Sump And The Collection Bottle Are Full Only applies to systems configured with the Split Waste Option Empty the external waste B collection bottle and Resume Waste B 0x01FA0015 4 External Waste B Collection Bottle Is Full Switch 29 Waste B Paused Replace Waste B Container and select Resume in Instrument Commands when ready CAU Extern...

Page 453: ...tact Beckman Coulter Technical Support Center for additional information 0x01FA0019 4 10 PSI Air Supply Pressure Is Low CAU 10 PSI Air Pressure Is Low Message ID 0x01FA0019 Description This error occurs when the transducer line 129 is outputting a value into the Hydro Board that is below the 10 psi specification Check pressure levels and HOME the system Adjust pressure levels if necessary First ad...

Page 454: ...01FA001C 4 17 psi air supply pressure is high CAU 17 psi air pressure is high Description This error will occur whenever there is a problem within the high pressure system If the High pressure reads higher than 19 psi for more than 15 seconds it will be flagged as High Check pressure levels and HOME the system Adjust pressure levels if necessary First adjust pressure in Main system above 17 psi Th...

Page 455: ...dge No fluid Detected Message ID 0x02620012 Subsystem RASched Chemistry Name Reagent Position Component Description Two consecutive reagent level sense errors for same cartridge cartridge is unusable Remove bubbles from cartridge neck or floating on reagent surface Reload reagent cartridge 0x02620017 2 CC Reaction Wheel Subsystem Motion Error CAU CC Reaction Wheel Subsystem Motion Error Message ID...

Page 456: ...r obvious obstruction of the sample probe or syringe Press the STOP button and HOME the system While system is homing observe motion of the CC sample syringe and CC Sample probe The probe and syringe should complete their operations in a smooth manner If the error continues check the event log to determine if the syringe or probe is responsible for the error If the CC sample probe is responsible p...

Page 457: ...ple 0x0262001B 4 Unrecovered CC Sample Probe Obstruction CAU Unrecovered CC Sample Probe Obstruction Message ID 0x0262001B Subsystem ccScheduler Description This error occurs when there was an Obstruction present at the CC sample probe The probe tried to clear the obstruction by flushing but the obstruction could not be removed The CC side of the system will finish any tests that are in progress a...

Page 458: ...ction of the CC reagent Probe A Press the STOP button and HOME the system While system is homing observe motion of the CC reagent probe A The probe should complete its operations in a smooth manner If the error continues check the event log to determine the specific subsystem error If event log indicates a vertical error make sure the reagent cartridges on the carousel are pushed in and seated pro...

Page 459: ...tion of the CC reagent Probe B Press the STOP button and HOME the system While system is homing observe motion of the CC reagent probe B The probe should complete its operations in a smooth manner If the error continues check the event log to determine the specific subsystem error If event log indicates a vertical error check that the reagent cartridges on the carousel are pushed in and seated pro...

Page 460: ...he system While system is homing observe motion of the CC reagent syringe The syringe should complete its operations in a smooth manner If the error continues contact Beckman Coulter Technical Support Center for additional information 0x02620021 2 CC Reagent Switch Motion Error CAU CC Reagent Switch Motion Error Message ID 0x02620021 Subsystem RASched Action Description This error will occur whene...

Page 461: ...t s housing HOME and restart the system 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 2 CC Sample Syringe Motion Error CAU CC Sample Syringe Motion Error Message ID 0x02620025 Subsystem RASched Action Name action name Description This error occurs when there is a...

Page 462: ...tion head and inspect probes for blockage and wiper for wear Check wash station wiper alignment Check wash station alignment Remove reaction carousel and check cuvette cleanliness Non resolution of problem may indicate photometer issues Contact Beckman Coulter Technical Support Center for additional information 0x02620034 4 CC Reagent probe disabled due to level sense errors CAU CC Reagent Probe D...

Page 463: ...uid on the sidewalls of the openings of the cartridge compartments This could cause false triggering of the level sense Cartridge must be reloaded to initiate level sense Check reagent probe alignment to and for any residual fluid in wash collar Consistent messages may indicate issues with the level sense function of reagent probe bead assembly reagent probe alignments level sense board Contact Be...

Page 464: ...o many tubes not venting correctly sampling for the CC probe will be stopped CAU CC Sample Probe Disabled due to Excess Pressure Errors Message ID 0x02620040 Subsystem ccScheduler Description Multiple tubes had excessive pressure in thick stopper closed tubes CC Sample Probe Disabled Check cap piercer for broken blade Perform CC ODC Alignment 0x02660001 4 No Diluent Cartridge CAU No diluent cartri...

Page 465: ...e volume Check proper rack assignment for type of container used reserved vs non reserved Look for fluid in collar wash fluid in collar wash can trigger false level sense Check alignment of sample probe in collar wash 0x02680002 4 CC Sample Obstruction Error Sample ID Rack ID Rack Position CAU CC Sample Obstruction Message ID 0x026800012 Subsystem RASched Sample ID Rack ID Position Description Thi...

Page 466: ...ncap tube and rerun If occurs consistently for many samples check cap piercer for broken blade Perform CC ODC Alignment 0x02680004 4 Sample tube did not vent correctly Remove cap and reload tube Sample ID sample id Rack rack id Position rack position CC Sample Probe CAU CC Sample Tube Excess Pressure Error Message ID 0x02680004 Subsystem RASched Sample ID sample id Rack ID rack id Rack Position ra...

Page 467: ...veral types of Photometer Smart Module PSM errors If for any reason the instrument Stops while the photometer is trying to read a cuvette the photometer will flag an error Check the Event Log for any messages that might indicate a problem around the same time stamp as the PSM Error Check the Cuvette Center Alignment for any cuvettes that exceed a 0 6 value This will flag a PSM Error Press the STOP...

Page 468: ...ansducer error Check Obstruction Detection Transducer for obvious leaks or dripping from connections or the device itself and CC Sample Probe Look for pinch in Water line from syringe to to top of probe Make sure the CC sample Syringe is properly seated Make sure CC Sample Probe tubing is properly connected at top of Probe Contact Beckman Coulter Technical Support Center for additional information...

Page 469: ...be damaged replace it extra cuvettes available in Spares kit and may be ordered Press the STOP button and HOME the system 0x04B2001C 4 MC Sample Level Sense Error Sample ID sample id Rack rack id Position rack position CAU Sample Level Sense Error Message ID 0x04B20001C Sample ID sample id Rack rack id Description This error occurs under following conditions The bottom of the container is reached ...

Page 470: ...ll attempt a second aspiration from this sample 0x04B2001F 4 Unrecovered MC Sample Probe Obstruction CAU Unrecovered MC Sample Probe Obstruction Message ID 0x04B2001F Description This error occurs when there was an Obstruction present at the MC sample probe The probe tried to clear the obstruction by flushing but the obstruction could not be removed The MC side of the system goes to a Stopped stat...

Page 471: ...and reload tube Sample ID sample id Rack sample rack id Position sample position MC Sample Probe CAU MC Sample Tube Excess Pressure Message ID 0x04B20027 Sample ID sample id Rack ID sample rack id Pos position Description Probe detected excessive pressure in thick stopper closed tube on second attempt Sample is aborted Uncap tube and rerun If occurs consistently for many samples check cap piercer ...

Page 472: ...eagent too low Message ID 0x04B30011 Subsystem Chem Name Description This error occurs when the MC sample probe does not sense reagent at the proper level or at all during the sample dispense into the cup module Check Reagent bottle volume Check Reagent tubing to straw connection is tight Make sure the straw is properly seated in the cap and reaches to the bottom of the reagent bottle Enable modul...

Page 473: ...U MC Sample Probe disabled due to obstruction errors Message ID 0x04B30013 Description More than 3 samples in a row had obstruction errors clots MC side Stopped Prime MC internal probe wash to make sure it is not obstructed Probe may need to be replaced If error continues perform MC ODC Calibration Alignment Table 13 10 Error Messages and Corrective Actions continued ID Class Pop up Event Log Desc...

Page 474: ...the bar code label on the rack If this occurs on a rack unload perform Unload All If the error continues compare the racks shown on the Main Screen with the racks present on the Sample Carousel to make sure the rack is physically present If on Main Screen but the rack is not physically present reboot system If on Main Screen and the rack is physically present shuttle latch may not have hooked the ...

Page 475: ... duplicate ID racks simultaneously Compare the number of the rack that was rejected with the racks currently on the analyzer by looking at the Main Screen Check the actual bar code that is on the rack correlates with the number that the system is rejecting Switch samples to a rack with a different ID or wait until the samples in the previous rack has completed testing and has been offloaded If the...

Page 476: ...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 4 Rack Height Not Defined CAU Rack height not defined Message ID 0x057A000E Subsystem SRShttl Description CTS is installed and the sample rack does not have a height defined Make sure that the ...

Page 477: ...HomeRgtMixerVer error occurred during a vertical movement away from the home sensor flag EnergizeRgtMixerCrn MoveRgtMixerToSensor error occurred during a horizontal movement toward the hardware sensor HomeRgtMixerCrane error occurred during a horizontal movement Raise canopy and check for obvious obstruction of the CC reagent mixer Press the STOP button and HOME the system While system is homing o...

Page 478: ... and HOME the system Check Event Log for specific RGTWHL subsystem errors Contact Beckman Coulter Technical Support Center for additional information 0x05DC01FD 2 CC Sample Mixer Error CAU Homing Error s Message ID 0x05DC01FD Description This motion error is contained within the Sample Mixer Crane and will only occur during a home This can be either a vertical or rotational error Make sure mixer h...

Page 479: ...ME print screen and check event log for specific sub system homing error and contact Beckman Coulter Technical Support Center for additional information 0x05DC0200 4 CC Subsystem Error CAU Homing Error for CC Subsystem Message ID 0x05DC0200 Subsystem boot homing command Description This is a generic homing error that occurs whenever their is an issue with the CC Subsystem This will normally be the...

Page 480: ...a AttachBun AttachGlu or AttachIse then the error occurred attaching to one of the MC modules If the parameter is InitCupsIse or PrimeCupsIse the error occurred during a cup or ISE initialize or prime for a stop or cold home If the parameter is WHomeMCIsePpsd or WHomeMCCups then the error occurred during a warm home of the ISE MC Sample Delivery subsystem or MC cups System Stopped Generic homing e...

Page 481: ...ufficient reagent PVT ERROR Insufficient reagent File filename line lineno Description Cannot perform the test because there is not enough reagent Load a new PVT reagent cartridge 0x13940014 7 PVT ERROR Insufficient sample PVT ERROR Insufficient sample File filename line lineno Description Sample Level Sense error while running PVT Pour a fresh PVT sample and restart the test 0x13940015 7 PVT ERRO...

Page 482: ...0037 9 Within Lot Cal Factor Timeout in hours Hours Chemistry chem Lot No lot no Serial No serial no Pos position STM Within Lot Cal Factor Timeout in hours Hours Chemistry chem Lot No lot no Serial No serial no Pos position Description The within lot calibration factor for the specified chemistry will timeout soon No operator action is necessary The next time a fresh cartridge of the specified ch...

Page 483: ...Pos position Description Specified reagent cartridge has less than 5 tests remaining Prepare to load another cartridge if another is not already on board 0x139F003A 9 MC Reagent container has low volume Reag chem Volume volume Lot no lot no Serial No serial no STM Reagent container has low volume remaining Reag chem Volume volume Lot no lot no Serial No serial no Description MC reagent container i...

Page 484: ...th the other networked instruments for any reason NOTICE TS CTS stands for Thick Stopper Closed Tube Sampling If a networked system has been shutdown and rebooted ignore this message If not check power to all Microhubs and network cable connections Select Status then F8 CTS Status to determine which instrument is no longer connected CAUTION To check a pre cut tube is not cut a second time any pre ...

Page 485: ... a rack usually due to a motion error The rack will be removed and processing will continue Correct the accompanying motion error and reload the rack 0x13A0001C 10 Non programmed samples on rack WLM Unprogrammed samps rack rack ID p PositionSample ID p PositionSample ID p PositionSample ID p PositionSample ID Description Rack has been loaded with a sample which has not been programmed Make sure th...

Page 486: ...librator levels in rack rack ID for the following calibrators calibrator name list WLM Missing calibrator levels Rack rack ID Calibrators calibrator list File Name Line Number Description Not all calibrator levels were loaded or were loaded out of order Reload calibrator racks Make sure bar codes are readable If there are 4 calibrators or less they must all be in the same rack If more than 4 level...

Page 487: ...059 10 Scanned barcodes in rack rack ID contain invalid characters Rack will unloaded from the sample carousel WLM Barcodescontain invalid chars Rack rack ID 1 sample ID 2 sample ID 3 sample ID 4 sample ID Description Sample bar code contains illegal characters Check the manual for illegal characters Make sure the complete bar code is visible and there are no smudges or wrinkles 0x13A0007E 10 Modu...

Page 488: ...be running Wait for samples to complete and system to go to Standby before requesting Maintenance procedure 0x13A20015 7 MAINT ERROR Motion MAINT ERROR Motion File filename line lineno Description Motion error observed while performing requested maintenance Test aborted no results are available HOME and restart the maintenance 0x13A20016 7 MAINT ERROR Reagent has not been loaded MAINT ERROR Reagen...

Page 489: ...Communication Line Down Check Event Log No new messages will be sent Review Host Comm Setup to re enable HC Chronic Host Port Communications Error Description Communications between the console and the host has been disrupted for a prolonged period of time Check to see that the Host is operating and responding to messages sent by the console Check the cable is correctly attached Check the LIS for ...

Page 490: ...e System will go to Standby automatically Select Pause only when at least one side of the system is running Reboot if necessary 0x13A70007 7 Instrument not in proper state ICMD Can t do SHUTDOWN in current instrument state File filename line line number Description System is not in proper state for Shutdown command Only select Shutdown when all sides of the system are in Standby Stopped or Disable...

Page 491: ...store Database Version number on disk doesn t match Database Version num File file Line line Description The contents of the backup are from a different version of the Console Software and cannot be restored on this version Use a newer disk if available 0x13AD0013 7 Error copying to floppy Backup Restore Error copying to floppy File file name Line line num Description System cannot identify insert...

Page 492: ... match Instrument serial number Backup Restore Inst serial number on disk doesn t match Inst serial num File file name Line line num Description Trying to restore from a disk for a different system Use another disk if available 0x13AD002B 7 S W Version on disk doesn t match MPC S W Version Backup Restore SW Version on disk doesn t match MPC SW Version File file name Line line num Description The c...

Page 493: ...ored on this version Use another disk if available 1391000E Cable Down lost connection to Instrument ROUTER Cable down detected mpcvan src cauman cau_router c 1675 Message ID 0x1391000E Description This Fatal Error will occur when a network connection has been lost and the computer console cannot communicate with the instrument Make sure that Instrument is on Check Ethernet cable connection at con...

Page 494: ...Common Error Messages and Corrective Actions Troubleshooting Calibration and Result Errors UniCel DxC Systems Instructions For Use A13914 Page 13 74 October 2005 ...

Page 495: ...component being measured Analytical Range 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 Results exceeding these limits will be flagged OIR HI or OIR LO O...

Page 496: ...ple Carousel upon completion Combined these two components allow for over one hour of uninterrupted sample processing with no operator intervention involved Auto ORDAC Automatic Overrange Detection and Correction A system feature that detects a chemistry result that exceeds the instrument analytical range Back to Back A measure of system precision during calibration The difference in the response ...

Page 497: ...hree levels of reagent Check Digit 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 Chromophore A colored substance th...

Page 498: ...le and reactants are mixed and in which the reaction is measured Cuvette Pathlength The distance light travels through fluid in a cuvette Pathlength is used as a measurement in absorbance Abs calculations Data Bits Low or high voltage signals transmitted through the serial communication data line Data bits are transmitted after a Start Bit and before the Parity Bit and Stop Bit The user can config...

Page 499: ...calibrator to provide IFCC DGKCh equivalent answers for selected enzymes Enzyme Verification A means of adjusting enzyme chemistry reporting to IFCC methods or to country specific correlation methods Electronic Maintenance Maintenance items are grouped together by frequency of performance Only the maintenance items appropriate for the particular system and installed hardware are shown On the Sched...

Page 500: ...host then sends the queried information to the system ICC Instrument Control Computer The central controlling processor of the system that provides large scale timing and communication with the MSMCs Icon A small pictorial representation of a functional area The icons are found on the menu bar at the top of the screen IFCC International Federation of Clinical Chemistry IFU Instructions for Use Imp...

Page 501: ...ll are also located in this area MSMC Multiple Smart Module Controllers Processors that work in conjunction with the ICC and communicate with the network of subsystems Multipage List A list that contains more than one screen page of information requiring use of Page Up Page Down to access additional pages Multipoint Span The difference between consecutive calibrator rates or absorbances The maximu...

Page 502: ...hat is associated with a patient such as name ID age or sex Pause An instrument command which allows results to be generated for all samples in progress before returning the instrument to Standby status Peltier A type of temperature control system that heats or cools depending on the ambient temperature Pop Up Window An information box that pops up to provide necessary system information A pop up ...

Page 503: ... that are verified at a site These ranges may or may not be the same as the analytical ranges depending on the needs of a site Results exceeding these limits will be flagged ORR HI or ORR LO Out of Reportable Range Reserved Racks A reserved rack may be used for uncapped primary or secondary tubes that have a small volume of sample for example nested cups on primary tubes Microtubes and pediatric c...

Page 504: ...grams 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 Examples of symbologies are Code 39 Code 128 Codabar and Interleaved 2 of 5 Target Value The known concentration of a cal...

Page 505: ...tober 2005 Page 11 of 12 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 ...

Page 506: ...DxC Terms Wash Concentrate Glossary UniCel DxC Systems Instructions For Use A13914 Page 12 of 12 October 2005 ...

Page 507: ...30 Enzyme validator 5 25 Error detection 2 49 Extending calibration time 5 28 Failure messages 5 20 Formulas Endpoint and first order 2 39 2 44 Non linear 2 45 2 46 Override 5 26 Reprint calibration report 5 34 Request Canceling a calibration request 5 19 Slope offset adjustment 5 32 Status 5 16 Touch screen 12 20 Within lot calibration 5 21 Designations 5 23 Enabling within lot calibration 5 21 F...

Page 508: ...rugs of abuse testing DAT 2 47 E Editing Control 6 11 EIC 10 86 EIC Electrolyte injection cup 10 2 EIC ports flushing 10 86 10 92 ISE service 10 86 Electrolyte injection cup EIC 2 15 Enable disable modules 11 22 11 23 Enzyme validator 5 25 Enzyme verification 2 48 Error detection See Calibration Error detection limits 9 16 Event log 12 8 Exit check criteria 9 21 9 22 Extinction coefficients 9 20 F...

Page 509: ...2 9 Priority load 2 9 Button 2 10 Probes wiping 10 12 Processing parameters 9 10 Programming samples 7 1 Batch 7 9 Dilution factor 7 8 Manual 7 8 Manual assignments 7 6 ORDAC 7 8 Rack status 7 2 Rack cup position 7 4 Sample ID 7 4 Sample status 7 3 Test selection 7 7 Pushers 2 10 Q Quad ring BUNm UREAm electrode 10 27 CO2 measuring electrode 10 81 Potassium and calcium electrode 10 60 10 71 Qualit...

Page 510: ...2 3 Operating temperature 2 3 STAT 4 18 Statistical summary report 8 13 Status Alarm Annunciator 4 43 See also System status 11 2 Status cycle count 11 4 Stop print 11 15 Surfaces and covers cleaning 10 117 Symbols 1 12 System configuration 4 41 System description 2 1 System Status 11 2 T Tables 4 11 Beckman Coulter defined chemistries 4 11 Predefined special calculations 4 26 Predefined special f...

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