Beckman Coulter UniCel DxC 600 Instructions For Use Manual Download Page 177

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A13914AF

5-13

Quality Control

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Summary of Contents for UniCel DxC 600

Page 1: ...Instructions For Use Volume 1 UniCel DxC Synchron Clinical Systems For In Vitro Diagnostic Use This manual is intended for UniCel DxC 600 UniCel DxC 800 UniCel DxC 600i Beckman Coulter Inc 250 S Kraemer Blvd Brea CA 92821 ...

Page 2: ...the property of their respective owners Find us on the World Wide Web at www beckmancoulter com Beckman Coulter Ireland Inc Mervue Business Park Mervue Galway Ireland 353 91 774068 Beckman Coulter do Brasil Com e Imp de Prod de Lab Ltda Estr dos Romeiros 220 Galpao G3 Km 38 5 06501 001 Sao Paulo SP Brasil CNPJ 42 160 812 0001 44 製造販売元ベックマンコールター株式会社東京都江東区有明三丁目 5 番 7 号 TOC 有明ウエストタワー贝克曼库尔特有...

Page 3: ...y Control Added Sample Integrity CHAPTER 3 System Setup Options Added footnotes to Table 3 3 UniCel DxC 600 Predefined Special Calculation Formulas and Table 3 4 UniCel DxC 800 Predefined Special Calculation Formulas CHAPTER 9 Maintenance Added Twice Weekly bullet to Maintenance Schedule Added Twice Weekly Maintenance Added bullets to Weekly Maintenance Added Twice Weekly Maintenance procedure Add...

Page 4: ...A13914AF iv Revision History ...

Page 5: ...azardous Materials Hazards Observe all laboratory policies or procedures which pertain to handling of infectious and pathogenic materials Closed Tube Sampling 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 ...

Page 6: ...ds Pinch hazard Keep fingers clear of the ISE module as you lower it Moving Parts Hazard Do not place hands near any moving part while the system is operating Lower and or close protective guards and covers during operation No Foam Reagent Pressurization Hazard The No Foam container is pressurized during system operation and must be properly depressurized prior to servicing to avoid sudden depress...

Page 7: ...te for Occupational Safety and Health Bulletin Explosive Azide Hazards 8 18 76 Avoid skin contact with reagent by using personal protective equipment If contact on skin occurs use water to wash reagent from skin Refer to the related Material Safety Data Sheets MSDS for additional information System Motors Hazards To prevent possible injury press the STOP button on the DxC System to disable the mot...

Page 8: ...f the AccuSense glucose oxygen sensor Air Filter Cleaning Precautions Do not place a damp filter back on the system Residual moisture may damage the system Alkaline Buffer Stability Precautions The alkaline buffer 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 Aqueo...

Page 9: ...e system Blood Barrier Collection Tube Precautions When blood collection tubes that contain physical barriers are used extra care should be exercised to ensure that the barrier is tightly packed Loose particles from the barrier could coat or plug the sample probe flow cell chemistry modules electrolyte injection cup EIC or cuvette wash station BUNm UREAm Electrode Precautions To prevent damage to ...

Page 10: ...sely affects the calcium Ion Selective Electrode ISE Electrostatic Discharge ESD Precautions To prevent damagedue to electrical staticdischarge ESD always wear thewrist ground strapwhen directed to in a procedure Environmental Conditions Precautions Changes in ambient temperatures and environmental conditions may result in a reference drift message In this case the electrolyte chemistries must be ...

Page 11: ...ead narrow margin bar codes Because of the sensitivity needed to read narrow margin bar codes the labels must be high quality They must be free from smudges spots or other imperfections An imperfection could be read as part of the Sample ID This could cause an inaccurate read of the bar code Obstruction Detection and Correction ODC Precautions Disabling ODC inactivates sample handling safeguards a...

Page 12: ... 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 you place your validated closed tubes on the DxC System check the top of the cap for any residual blood Residual blood contamination into the sample could af...

Page 13: ... may cause results to be received at the host and printed at the DxC without the sample ID Depending on the host implementation this can cause lost sample results or sample results which merge with other sample results producing duplicate tests or added tests Sample Use Precautions Do not use the same sample run on a DxC system for analysis of analytes for which a small quantity of carryover could...

Page 14: ...tem however performing the Restore function deletes some or all files depending on the areas restored from the hard drive Urine Sample Precautions After analysis of ten consecutive urine electrolytes run one replicate of electrolytes on Synchron Calibrator Level 2 in the serum mode This minimizes the potential for chloride drift due to matrix effects of urine samples ...

Page 15: ...r switch indicates that 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 t...

Page 16: ...e left of this symbol indicates the power is ON CPU Power OFF Switch This symbol is located on the face of the Computer CPU unit and indicates the OFF state when pressed Primary Electrical Ground This symbol is used to indicate an electrical ground Keyboard Connection This symbol is found above the connection between the computer and the keyboard ...

Page 17: ...e the probe Do Not Hold This Object Here This red symbol located on the top of each sample and reagent probe assembly indicates that this area may not be handled Mouse Port Connection This symbol is found next to the connection between the computer and the mouse port High Voltage Electric Shock Risk This symbol indicates high voltage is present and or there is a risk of electric shock when working...

Page 18: ...on to operate only with all covers in place to reduce risk of personal injury or biohazard General Biohazard These caution symbols indicate biohazardous risk from possible patient specimen contamination Laser Bar Code Caution A label reading CAUTION LASER LIGHT ACCESSIBLE WHEN COVER IS OPEN OR REMOVED DO NOT STARE INTO BEAM is placed on the cover of any laser based code reader Do not stare into la...

Page 19: ...VOID 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 AND MAINTENANCE TO QUALIFIED SERVICE PERSONNEL is found on top of the optional cap piercing hardware which is located underneath the removable cover of the cap...

Page 20: ...CAUTION PARTS MOVE AUTOMATICALLY is placed inside the offload track on the left side of the back wall MC Door Caution A label 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 A012937L EPS THE ISE COVER SHOULD REMAIN IN PLACE DURING SYSTEM OPERATION 471830...

Page 21: ...he Run and Priority Load buttons and indicates the correct position of a rack for placement into the autoloader Laser Certification Label This label is found on the back bottom edge of the system It provides information about the laser A012939L EPS 270 455774 A CAUTION READ MANUAL BEFORE OPERATING ATTENTION CONSULTER LA NOTICE AVANT DE FAIRE FONCTIONNER A011540L EPS BECKMAN COULTER INC MADE IN U S...

Page 22: ...tifies connections for the Ethernet and serial ports Fluid Interface Label This label is found on the center back bottom edge of the system It identifies inlet and outlet ports on the system A012942L EPS ETHERNET SERIAL PORT A012943L EPS WASTE B OUTLET WASTE OUTLET WASTE B SENSOR D I WATER INLET MAX PRESS 100 PSI 689 kPa 136 137 128 D I FIBER ...

Page 23: ... the device is not to be disposed of 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 productsthat have this label please contact your dealer or local Beckman Coulter office for details on the take b...

Page 24: ...tal protection use period for the product The outer circle indicates that the product can be recycled The logo also signifies that the product should be recycled immediately after its environmental protection use period has expired The date on the label indicates the date of manufacture RoHS Environmental Label This logo indicates that the product does not contain any toxic or hazardous substances...

Page 25: ...ry May be used to indicate the possibility of erroneous data that could result in an incorrect diagnosis does not apply to all products CAUTION CAUTION indicates a potentially hazardous situation which if not avoided may result in minor or moderate injury It may also be used to alert against unsafe practices May be used to indicate the possibility of erroneous data that could result in an incorrec...

Page 26: ...A13914AF xxvi Safety Notice Documentation Symbols ...

Page 27: ...eagent Handling System 1 17 Cuvette Reaction System 1 21 Hydropneumatic System 1 24 Operation and Control Components 1 26 Main Screen and Program Structure 1 27 Theory of Operation 1 43 Cartridge Chemistry Calibration Theory 1 43 Modular Chemistry Calibration Theory 1 53 Cartridge Chemistry Principles of Measurement 1 54 CHAPTER 2 Preparing Samples for Analysis 2 1 Routine Operation Overview 2 1 P...

Page 28: ...ical Ranges Setup 3 19 Sample Comments Setup 3 19 Special Calculations Definition 3 20 Timed Urine and Creatinine Clearance Results 3 23 Version Information 3 23 Units Precision Setup 3 24 User Defined Chemistries Setup 3 24 Bar Code Setup 3 25 Maximum Sample Program Age 3 26 Reserved Racks Obstruct Detect 3 26 Disable Service Monitor 3 27 Host Communications 3 28 Language Keyboard Setup 3 29 Prin...

Page 29: ...hemistry Bypass 4 25 Extend Calibration Time 4 26 Calibration Acceptance Limits 4 27 Calibrator Set Point Modifications 4 28 Slope Offset Adjustment 4 29 Reprint Calibration Reports 4 31 CHAPTER 5 Quality Control 5 1 Quality Control 5 1 Define a Control 5 4 Control ID Assignments 5 7 Run Control Samples 5 7 Edit a Control Definition 5 9 Review a Control Definition 5 12 Delete a Control 5 12 Print ...

Page 30: ...ID 7 4 Recall Results by Run Date Time 7 4 Display Recalled Results 7 5 Edit Critical Rerun Result 7 6 Print Recalled Results 7 7 Send Results to the Host 7 8 Absorbance Versus Time 7 8 Statistical Summary Report 7 10 CHAPTER 8 User Defined Reagents 8 1 Overview 8 1 Requirements and Precautions 8 1 User Defined Reagent Setup 8 3 Chemistry Parameters 8 4 Processing Parameters 8 8 Error Detection Li...

Page 31: ...nance 9 52 As Needed As Required Maintenance 9 64 CHAPTER 10 System Status and Commands 10 1 Overview 10 1 System Status 10 1 Status Cycle Count 10 2 Temperatures 10 3 Show Temperature Status 10 3 Power Subsystems 10 4 Hydropneumatics Subsystem 10 4 ICS Smart Modules 10 5 Cuvette Water Blank Status 10 6 CTS Tracking 10 7 Instrument Commands 10 8 Home 10 8 Pause 10 9 Stop Print 10 11 Shutdown 10 12...

Page 32: ...Calibration 11 16 CHAPTER 12 Troubleshooting Calibration and Result Errors 12 1 Calibration Errors 12 1 MC Calibration 12 2 Linear Calibration 12 7 Non Linear and Multipoint Calibrations 12 10 Troubleshooting Result Errors 12 13 Error Codes and Definitions 12 14 Error Code Definitions 12 17 Common Error Messages and Corrective Actions 12 1 Glossary Glossary 1 Index Index 1 Related Documents ...

Page 33: ...tructions are not included in this manual In addition medical and diagnostic interpretation or the clinical significance of chemistries or assays are not discussed Refer to the reference materials in the Related Documents section for detailed information Manual Conventions This manual uses the following printed and visual cues to guide the user in responding to printed directions Table 1 Conventio...

Page 34: ...se or initial caps Example Press the STOP button Keyboard keys Keyboard keys are enclosed in Examples X Tab Enter Pull down menus Use the pull down menu to see a list of options you can select Example Select the Calibrator Name pull down menu at the top of the Assign Barcode Rack dialog box to view the list of calibrators Text field Names in the text fields are bold and use a SansSerif font follow...

Page 35: ...st be made at a step within a procedure An indented decision list is then presented which describes the variable conditions in the first bullet and the appropriate action for each condition in the subordinate bullets Example of a Procedure The following is an example of a procedure that contains a decision list 1 Select Rerun F6 To enter individual Sample IDs Type the Sample IDs for rerun in the S...

Page 36: ...A13914AF xxxvi Introduction How to Use this Manual ...

Page 37: ...ional Conditions Shipping Damage Each DxC System is carefully examined and checked by Beckman Coulter Inc before it is shipped When you receive your new DxC System visually inspect the shipping container for damage If there is damage notify the Beckman Coulter Service representative before he or she arrives at your facility to install your system Installation Table 1 1 Installation Requirements It...

Page 38: ...ces Area Affected Clearance Needed Left Side Minimum of 6 inches 15 2 cm clearance or 12 inches 30 5 cm to access smart modules Right Side Minimum of 18 inches 45 7 cm clearance when monitor on swing arm is in use Back Zero inches The venting design of the system allows for 0 inch clearance at the back Top Minimum of 22 inches 55 9 cm from highest point of system Front Minimum of 25 inches 63 5 cm...

Page 39: ...tem Requirement Operating range 100 120 VAC 10 90 132 VAC 4A OR 200 240 VAC 10 180 264 VAC 2A Frequency 50 60 Hz BTU generated 1 500 BTU hour Power connector 15 A current rating IEC 320 standard connector Table 1 5 Power Requirements Okidata B4350 LED Printer Item Requirement Operating range 110 127 VAC 10 99 140 VAC 3A OR 220 240 VAC 10 198 264 VAC 1 6A Frequency 50 60 Hz BTU generated 1228 BTU h...

Page 40: ...rts per billion ppb Not Applicable Microbiological Impurities Maximum microbial content colony forming unit CFU mL 10 CFU mL 10 CFU mL Ionic Impurities Minimum resistivity megohm centimeter MΩ Cm 25C 10 MΩ Cm 1 0 MΩ Cm Particulate Colloid Content Purification process requirement only water filtration using 0 22 μm pore size to remove microorganisms and particulates Purification process requirement...

Page 41: ... 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 Maximum Leakage Current DxC 600 222 μA at 240V 50Hz DxC 800 240 μA at 240V 50Hz Table 1 9 IEC 1010 Specifications Item Specification Equivalent to Near Infrared Particle Immuno A...

Page 42: ...code reader Cap piercer assembly optional Sample Carousel Sample probe mixer assemblies The sample handling module is used to load samples onto the system provide samples for analysis and provide temporary storage of completed samples A detailed description of each component is presented in the following paragraphs 1 Modular Chemistry MC Section 2 Cartridge Chemistry CC Portion 3 Autoloader 4 Dual...

Page 43: ... Adapters are provided to adapt various sized sample tubes secondary tubes to the short racks These adaptors must only be used in racks designated as reserved The reserved rack feature is described in CHAPTER 3 System Setup Options Table 1 10 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...

Page 44: ...n Sample Handling System Rack ID Labels Sheets of bar coded rack ID labels are supplied with the system They can be applied as shown in Figure 1 2 Figure 1 2 Rack 1 Numeric Rack ID Number 2 Rack Size Label 3 Bar Coded Rack ID Label ...

Page 45: ... completion IMPORTANT When loading racks onto the autoloader make sure that they are placed firmly down into the autoloader Figure 1 3 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 posi...

Page 46: ...ves 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 Shuttle The Shuttle moves the rack from the gate area onto the Sample Carousel Refer to Figure 1 3 Bar Code Reader Sample CAUTION Do not tamper with or remove the housing of the Sample Bar Code Reader The Bar Code Reader is a Class II fixed beam l...

Page 47: ...eed for cap removal Tubes with caps must be loaded in racks that have had the size correctly defined and that are not Reserved Reserved Racks No CTS Both open and closed tubes can be in the same sample tube rack Refer to Documentation Symbols in the Safety Notice section for a description of the CAUTION labels for the Cap Piercer Table 1 11 Tubes Validated for Closed Tube Sampling Cap Piercer Conf...

Page 48: ... are reserved for priority racks Figure 1 4 Sample Carousel Area Modular Chemistry MC System Introduction The Modular Chemistry system consists of the following major assemblies Reagent storage area Ratio pump Sample probe Electrolyte injection cup EIC Flow cell assembly Chemistry reaction modules A detailed description of each component is presented in the following paragraphs 1 Liquid Level Sens...

Page 49: ...on the ISE module Figure 1 5 Modular Chemistry Reagent Storage Area Reagent Bar Code Reader Modular Behind the left side door of the system there is a hand held bar code reader Refer to Figure 1 5 When this reader is held up to the label of one of the modular reagents and the trigger is pressed the identity of the reagent the lot number and reagent volume are automatically entered into the reagent...

Page 50: ...acement pump used to deliver the necessary reagents to the ISE flow cell Refer to Figure 1 6 It consists of a three step piston housed in three stacked independent cylinders Figure 1 6 DxC 800 Ratio Pump 1 Solenoid Valve example 2 Cylinder 1 3 Cylinder 2 4 Cylinder 3 5 Outlet Line example 6 Inlet Line example A015904P EPS 6 5 4 3 2 1 ...

Page 51: ... System 1 Electrolyte Injection Cup EIC The EIC mixes the sample and buffer prior to delivery of the sample now diluted to the flow cell Figure 1 7 Electrolyte Injection Cup 1 Waste Outlet 2 Flow Cell Outlet 3 Buffer Inlet 4 Reference Inlet 5 DI H2O Inlet ...

Page 52: ...electrodes that perform the analysis of sodium potassium chloride carbon dioxide and calcium Figure 1 8 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 53: ...ponents of Modules Ex Albumin Cartridge Chemistry CC Reagent Handling System Introduction The Cartridge Chemistry Reagent Handling system is composed of the following components Reagent cartridges Reagent carousel Reagent probe assembly Reagent mixer assembly Mixer wash cup The Reagent Handling system is used to transfer reagent from the individual cartridges to the reaction cuvettes for processin...

Page 54: ...Reagent cartridges are single use recyclable plastic containers that house the individual liquid reagent components necessary to perform a chemistry test The reagent carousel is capable of storing 59 cartridges on board Figure 1 10 CC Reagent Cartridge 1 A Compartment 2 B Compartment 3 C Compartment ...

Page 55: ...torage compartment is refrigerated and fan cooled to maintain a temperature of 5 C 3 C The Bar Code Reader refer to Figure 1 11 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 Figure 1 11 CC Dual Carousel...

Page 56: ...to Figure 1 12 Figure 1 12 CC Reagent Probe Area Reagent Mixer 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 1 12 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 1 Reagent Mixer 2 CC Reagent Probe A 3 CC Rea...

Page 57: ...om 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 1 13 supports a total of 125 cuvettes Each cuvette is glass with a 0 5 cm path lengt...

Page 58: ... 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 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 the left of the photometer assembly near the sample carousel Refer to Fi...

Page 59: ...on refer to Figure 1 14 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 1 14 Cuvette Wash Station 1 Probe 1 2 Probe 2 3 Probe 3 4 Probe 4 5 Wash Station ...

Page 60: ...Refer to Figure 1 15 and Figure 1 16 When fully extended the drawer locks open To close lift up on the metal tabs located on each side of the bottom runner of the hydropneumatic unit and push the drawer inward Figure 1 15 DxC 800 Hydropneumatics right side 1 Wash Concentrate Solution 2 No Foam Reagent 3 DI Water Canister 4 Wash Solution Canister 5 Wash Concentrate Reservoir 6 Auto Gloss A016497P E...

Page 61: ...llowing media to the different functional areas of the instrument Vacuum Compressed air Diluted wash solution Deionized water Figure 1 16 DxC 800 Hydropneumatics left side 1 Waste B Exit Sump 2 Waste Exit Sump 3 DI Water Inlet On Off 4 Waste Sump 5 Waste B Sump 6 DI Water Reservoir 7 Vacuum Accumulator A015911P EPS 2 4 5 6 7 1 3 ...

Page 62: ...re 1 3 are used to start the process to prioritize a sample run or to stop the process under certain conditions as described in Table 1 12 Table 1 12 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 rack into a priority position on the sam...

Page 63: ...e initiated from the Main screen at the DxC analyzer refer to Figure 1 17 In addition the screen provides status information to help determine the present state of the system Figure 1 17 UniCel DxC 800 Main Screen 1 CTS Indicator 2 Host Indicator 3 System Status Indicator 4 Menu Bar 5 Sample Status Icons 6 Rack Status Area 7 Function Bar E011950S EPS 5 6 7 4 3 1 2 ...

Page 64: ... option if a CTS assembly is installed otherwise that selection is grayed out on the Setup screen The default for CTS sampling is OFF Host This indicator 2 in Figure 1 17 appears on the blue bar at the top right side of the Operator screens The indicator to the right of the label shows communication activity between the instrument and the host computer A blue bar indicates that the host is sending...

Page 65: ...le 1 14 Sample Status Indicators Status Indicator Status Description Not Programmed Indicates a sample has been loaded without any programming associated with that Sample ID Query Pending Sample is waiting for specific program information to be downloaded from the host In Progress Sample has been identified and is currently being processed Aspirated Indicates whether an initial aspiration of the s...

Page 66: ...m Structure Menu Bar Icons and Program Structure Near the top of the Operator screens a series of icons on the touch screen provide access to each of the major functional areas of the system 4 refer to Figure 1 17 Figure 1 18 Program Structure Main Samples ...

Page 67: ...A13914AF 1 31 System Description Main Screen and Program Structure 1 Figure 1 19 Program Structure Results Rgts Cal ...

Page 68: ...A13914AF 1 32 System Description Main Screen and Program Structure Figure 1 20 Program Structure QC Setup ...

Page 69: ...A13914AF 1 33 System Description Main Screen and Program Structure 1 Figure 1 21 Program Structure Setup continued ...

Page 70: ...A13914AF 1 34 System Description Main Screen and Program Structure Figure 1 22 Program Structure Setup continued ...

Page 71: ...A13914AF 1 35 System Description Main Screen and Program Structure 1 Figure 1 23 Program Structure Utils ...

Page 72: ...A13914AF 1 36 System Description Main Screen and Program Structure Figure 1 24 Program Structure Utils continued ...

Page 73: ...A13914AF 1 37 System Description Main Screen and Program Structure 1 Figure 1 25 Program Structure Utils continued Status Instr Cmd and Help ...

Page 74: ... manual opens up full screen in the language selected in System Setup You can use the combination keys ALT F1 to toggle between the active screen and the last accessed page of the online manual Online Manual Links Thesystem may display an Error The page cannot bedisplayed pop up messagewhenyouselect the Event ID button to link to the online manual from an instrument pop up error message or when yo...

Page 75: ...ted on samples for example incomplete tests host query timeout duplicate sample ID programming conflict If the error is logged the Log F8 key is highlighted in yellow The yellow highlight disappears when the key is selected The error will stay in the Sample Log screen for 12 hours Pre Run Summary F9 Lists reagent and calibration status as well as sample programming needs Post Run Summary F10 Lists...

Page 76: ...RINT Exit and return to the Main screen OK Table 1 16 Sample Log Fields Field Description Rack The rack in which the sample was run Position Pos The position of the sample in the rack when it was run Sample ID There are two ways to get this sample ID 1 The system reads the bar code 2 Manually input a sample program If there is no sample ID there are two possible fields If there is no sample ID the...

Page 77: ...ations for some of these errors If some CC results are still incubating the sample status shows Removed when it is first taken off the sample carousel In this case the sample is deleted from the list when it goes to Complete If it does not go to Complete more status strings are added as applicable Possible statuses are listed below Duplicate Sample ID Editing Sample Programming Conflict Barcode ID...

Page 78: ...y in the Main screen select the Main icon from the menu bar 2 Select Pre Run F9 The Pre Run summary prints automatically It may take up to 25 seconds to start to print Post Run Summary The Post Run Summary option provides a printed list of the samples that are pendingorincomplete with an explanation of the status Incomplete or Suppressed tests are generated due to a reagent or calibration situatio...

Page 79: ... operation a number of events occur simultaneously and are under direct control of the instrument microprocessors Cartridge Chemistry Calibration Theory Introduction Calibration determines the relationship between measured reaction responses and known concentrations Calibration factors are derived from this relationship These factors are used to convert the measured reaction responses to final con...

Page 80: ...ion factors based on four calibratorreplicates per calibratorlevel The instrument will determineanddiscardthehighest and lowest of the four replicates The remaining two values are called the usable calibrator replicates All four replicates will appear on the report but the average of the two usable replicates is used to determine the calibration factor For other chemistries calibration is based on...

Page 81: ... point and the offset is equal to zero BlankedEndpoint Chemistries FOR HIGH CALIBRATOR LEVEL Reaction ABS Blank ABS Delta ABSrep1 Reaction ABS Blank ABS Delta ABSrep2 Delta ABSrep1 Delta ABSrep2 0 5 Delta ABSavg hi FOR LOW CALIBRATOR LEVEL Reaction ABS 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 Del...

Page 82: ...p2 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 IMPORTANT For single point linear calibration the low calibrator is a fixed zero point and the offset is equal to zero Table 1 17 Calculation of Calibration Factors for Endpoint and Rate Chemis...

Page 83: ...erep1 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 IMPORTANT For single point linear calibration the low calibrator is a fixed zero point and the offset is equal to zero Table 1 17 Calculation of Calibration Factors for Endpoint and Rate Chemistries Continued Type Formula E0...

Page 84: ...nk 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 IMPORTANT For single point linear calibration the low calibrator is a fixed zero point and the offset is equal to zero Tabl...

Page 85: ...tion 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 IMPORTANT For single point linear calibration the low calibrator is a fixed zero point and the offset is equal to zero Table 1 17 Calcu...

Page 86: ... 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 based on two to four replicates of each ca...

Page 87: ... a five parameter logit function This function 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 ...

Page 88: ...lent to model 1 If c 1 an alternative function is being used This function cannot be solved directly for concentration The instrument uses an iterative method to determine the sample value Polynomial Exponential PXP Quadratic POLY2 Lorentz Double Inflection Model DP4 Table 1 18 Math Models for Non Linear Chemistries Continued Type Formula E014476L EPS E014477L EPS E014478L EPS E011537L EPS R Kc1 K...

Page 89: ...ws results to be adjusted for country specific correlation needs Verification is similar to calibration except that normalization factors are applied to the sample result in the form of a slope and offset adjustment whereas calibration factors would be applied to the reaction response Modular Chemistry Calibration Theory Calibration Theory Modular chemistries are calibrated using two to three leve...

Page 90: ...system can measure this as an endpoint or a rate of formation Table 1 19 Methodology and Modules Used with Modular Chemistries Chemistry Methodology Module Sodium Ion selective electrode ISE ISE Flow cell Potassium Ion selective electrode ISE Flow cell Chloride Ion selective electrode ISE Flow cell Carbon Dioxide pH electrode ISE Flow cell Calcium Ion selective electrode ISE Flow cell Urea Nitroge...

Page 91: ... system setup has been completed 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 RUN 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 Standby...

Page 92: ...ample Racks Sample racks accept the following tube and cup sizes IMPORTANT Adapters are provided to adapt various sized sample tubes secondary tubes to the short racks These adaptors must only be used in racks designated as reserved The reserved rack feature is described in this chapter Table 2 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 ...

Page 93: ... Place into a 13 100 mm rack Pipette the sample into a Synchron Microtube Make sure there are no bubbles at the bottom of the tube A reserved rack must be used Sample Cup 0 5 mL PN 651412 2 0 mL PN 652730 or 81902 Place the cup into a 13 75 mm or a 13 100 mm rack OR Place the cup in 15 85 mm tube into a 16 100 mm rack Make sure there are no bubbles in sample If cup is placed in a 15 85 tube with a...

Page 94: ... A misread label can cause one sample ID to be read as another The laboratory s process for printing placing and meeting all bar code specifications is important to achieve highly accurate reading Follow the bar code label specifications to keep the rate of misread labels to a minimum Bar Code Label Placement Bar code labels must be applied to each sample tube in the correct location so that the b...

Page 95: ...feature that allows the system to pierce primary sample 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 When a particular Sample ID is manually cleared through Sample Programmin...

Page 96: ...r rolls over and uses the same Sample IDs again clear the Sample IDs at any of the instruments connected by the tracking network Follow the steps below to verify Sample ID clearing status 1 Select Samples from the menu bar 2 Type the sample ID 3 Press Enter 4 Does the sample have its initial program If the sample has its initial program Do NOT remove its cap Run the sample If the sample does NOT h...

Page 97: ...nto one of these fields any samples run in that rack will only function for that specific test For example Rack 66 is entered into the Reserved Racks for HbA1c field Any sample placed in that rack can only have an HbA1c HbA1c2 run on it The reason for this is that each test in this group requires some sort of sample preparation If these tests are part of a group of other tests that do not require ...

Page 98: ...wn on the right side of the screen 3 Select 17 Reserved Racks Obstruction Detection The following screen appears Figure 2 2 Reserved Racks Obstruction Detection Setup Dialog Box 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 E015928S EPS ...

Page 99: ... System Setup Options Overview Introduction This chapter summarizes the 29 System Setup options depicted on the Setup screens shown in Figure 3 1 and Figure 3 2 below Figure 3 1 Setup Screen scrolled to the top E011951S EPS ...

Page 100: ... allows the operator to Assign up to 100 user names and their passwords Assign Administrator or Operator level privileges to each user name Define edit or delete user name password setup Enable disable security for accessibility to certain system functions and setups The following features may be password secured Results Edit Rgts Cal Modify Set Points Rgts Cal Slope Offset Adjustment Rgts Cal Wit...

Page 101: ...d security If necessary select Page Down on the right side of the screen to show the user desired Select New F1 to enter the password setup for a new user 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 Select Define F2 5 In the Define Edit Password dialog box enter the information requested IMPORTANT Do NOT type be...

Page 102: ...programming are run at the ORDAC sample volume From the Setup screen select1 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 Standby Stopped Startup Instrument Down or Homing to modify the ORDAC selection IMPORTANT The analytical ranges for each analyte are system limits found in ...

Page 103: ...match the test order on the lab request forms Modular chemistries MC are permanently configured on the system These chemistries may be relocated on the configuration screen but not removed BUNm and UREAm are both displayed as available chemistries on the DxC 800 However only one may be configured at a time The selected chemistry is configured during software installation The Chem Configuration Def...

Page 104: ... following that position are incremented by one position If 180 is exceeded the last one is dropped From the Setup screen select 2 Chemistry Configuration Sample Type Refer to the UniCel DxC Synchron Clinical Systems Reference Manual for additional information on this procedure Deleting a Chemistry The Delete Chemistry function requires that you first clear the calibration sample programming and c...

Page 105: ...Select Load F1 When prompted by the instrument to remove the reagent cartridge open the reagent carousel door to remove the cartridge The reagent cartridge may be scanned off if it has a bar code or select Clear F1 to remove reagent data Close the reagent carousel door Remove the Chemistry from Sample Programming Example DIGN IMPORTANT All samples in the sample required incomplete and rerun status...

Page 106: ...C Synchron Clinical Systems Reference Manual Clearing Samples section for information on how to clear sample programming Remove the Chemistry from the Quality Control QC Program If a control is defined solely for that chemistry and is no longer needed the entire control definition should be deleted 1 Select QC from the menu bar 2 Select the control to be cleared 3 Select Delete F3 4 The following ...

Page 107: ...emistry name Press Page Up or Page Down keys to access all chemistries Select OK to leave the selection screen and save the changes 5 The following message appears to confirm the clearing of the selected chemistries from the control QC data and statistics for this chemistry will be deleted Archiving is suggested Deselect this chemistry Select OK to remove the chemistry from this control Deleting a...

Page 108: ... Alanine Aminotransferase Pyridoxal 5 Phosphate ALT IU L X Albumin ALB g dL X X Albumin modular ALBm g dL X X Alkaline Phosphatase ALP IU L X Ammonia AMM μmol L X Amphetamines AMPH mA min X XX Amylase AMY U L X Antistreptolysin O ASO IU mL X X Apolipoprotein A 1 ApoA mg dL X X Apolipoprotein B ApoB mg dL X X Aspartate Aminotransferase AST IU L X Aspartate Aminotransferase Pyridoxal 5 Phosphate AST...

Page 109: ...rase GGT IU L X Gentamicin GEN μg mL X X Glucose GLU mg dL X Glucose GLUCm mg dL X Haptoglobin HPT mg dL X HDL Cholesterol direct HDLD mg dL X X Hemoglobin A1c HbA1c X X Hemoglobin A1c2 HbA1c2 X X Immunoglobulin A Ig A mg dL X Immunoglobulin G Ig G mg dL X Immunoglobulin M Ig M mg dL X Iron FE μg dL X Lactate LAC mmol L X X Lactate Dehydrogenase LD IU L X Lactate Dehydrogenase LD P IU L X LDL Chol...

Page 110: ... X X Theophylline THE μg mL X X Thyroxine T4 μg dL X X Tobramycin TOB μg mL X X Total Bilirubin TBIL mg dL X X Total Iron Binding Capacity IBCT μg dL X Total Protein modular CSF TPm mg dL X Total Protein modular 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 mo...

Page 111: ...ore date and time defaults The first time the instrument is powered up the user must set the date and time When set changes to accommodate situations such as converting to daylight savings time are performed through this option The Date Time screen may be viewed at any time but may only be modified when the system status is Standby Stopped Startup Instrument Down or Homing Setup To access Date Tim...

Page 112: ...r send results to the Host as they are completed on the system When these options are not selected test results are not printed or sent to the Host until all tests are completed for the sample ID Immediate Patient Results Reporting to Host and or Printer From the Setup screen select 5 Immediate Report to change settings for Immediate Reporting To change Immediate Reporting settings the system must...

Page 113: ...ption allows grouping of analytes commonly programmed and run together Defining Editing and Deleting Panels The operator may define a maximum of 50 panels and must assign a unique name to each From the Setup screen select 6 Panels to show the Panel Summary screen then select Define F1 to define edit or Delete F2 to delete panels Panel definitions may be viewed and modified at any time Selecting a ...

Page 114: ...he system Default Replicates value The Replicates option may be viewed at any time The system must be in Standby or Stopped state to change replicates The default for replicates is 1 Report Setup Introduction This feature allows the operator to select the following options Enable or disable printing of Patient and Control Reports Define a Report Header to print at the top of each report Select fro...

Page 115: ... Range Analytical Range The Analytical Range is an internal system limit verified by Beckman Coulter Refer to the Synchron Clinical Systems Chemistry Information Manual and the Synchron Clinical Systems Chemistry Reference Manual for Analytical Ranges by analyte Instrument Printable Range The Instrument Printable Range is an internal system limit specified in the Reportable Range Setup screen The ...

Page 116: ...C will not suppress or flag results based on Reportable Range Suppress Results Option For each analyte and sample type the operator may enable or disable the Suppress Results option Results exceeding the Reportable Range are always flagged If the Suppress Results check box is not checked the result number is printed on the report and sent to the LIS along with the remark When the Suppress Results ...

Page 117: ...nalyte The operator may delete one result or send both to the host The Critical Results Rerun option should not be enabled for analytes with POS or NEG result reports such as the drug of abuse tests DAT From the Setup screen select 10 Reference Critical Ranges to define edit delete view or set a default Reference and Critical Ranges may be viewed while the system is running The system must be in S...

Page 118: ...ation is enabled the value is reported only if the appropriate chemistries for the equation are programmed and run for a given sample ID The system uses the full precision of the test s results when performing special calculations If you manually calculate using results that have been rounded the results will be similar but they will not match exactly From the Setup screen select 12 Special Calcul...

Page 119: ... Thyroxine None X X Serum CREA Clearance 1 mL min X X Timed Urine CREA Clearance 2 mL sec X X Timed Urine ApoA ApoB Ratio None X X Serum ApoB ApoA Ratio None X X Serum Hemoglobin A1c X X Serum Hemoglobin A1c2 X X Blood Hemoglobin A1c SI mmol mol X X Serum Hemoglobin A1c2 SI mmol mol X X Blood Table 3 3 UniCel DxC 600 Predefined Special Calculation Formulas Calculation Formula Osmolality 1 1 86 NA ...

Page 120: ... 2 1 86 NA GLUCm 18 UREAm 9 Anion Gap 1 a a For a review of anion gap please refer to Kraut JA Madias NE Serum anion gap its uses and limitations in clinical medicine Clin J Am Soc Nephrol 2007 Jan 2 1 162 74 NA CL CO2 Anion Gap 2 a 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 ...

Page 121: ...n 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 deciliter or liter Therefore the factors applied to total volume will only be as follows milliliters to milliliters 1 0 milliliters to deciliters 0 01 milliliters to liters 0 001 For examples of Timed Urine Calculations refer to the Uni...

Page 122: ...p 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 in Standby Stopped Startup Instrument Down or Homing to change unit selection or decimal places Refer to the default chemistry units and precision in Table 3 1 User Defined Chemistries Setup Introduction With...

Page 123: ...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 Stopped Startup Instrument Down or Homing to make mo...

Page 124: ...creen select 16 Bar Code and check the box beside Maximum Sample Program Age to enable this feature The operator can enter the time limit in hours or days The system must be in Standby or Stopped to make changes The default is disabled Reserved Racks Obstruct Detect Introduction The Reserved Rack Obstruction Detection option allows the operator to Enable disable the CTS Cap Piercer option Enable d...

Page 125: ...ator must Stop and Home the system to completely enable the feature Defaults CTS Off Obstruction Detection On Reserved Racks None Reserved Reserved Racks for HbA1c or IBCT None Reserved Disable Service Monitor Introduction The Disable Service Monitor option permits the service monitor to be disabled When the Metering Counter is activated the Service Monitor must be disabled Refer to the Synchron C...

Page 126: ...or 2 NA 1b ASTM Header Short or Long Short 3 Digit Rack Number Selected or Not Selected CX7 Compatible only Not Selected Device ID 0 99 0 Flow Control Software XON XOFF Hardware RTS CTS c or none c For Flow Control do not select the Hardware RTS CTS option With the Hardware option ESD interference may affect the performance NA Software XON XOFF Data Transmission Mode Transmission OFF Unidirectiona...

Page 127: ...eters Language Keyboard Setup Introduction The Language Keyboard Setup option allows the operator to select from the following languages and keyboards for instrument operation English French German Italian Spanish Japanese Simplified Chinese 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 ...

Page 128: ... support personnel to access several service features on the system Entering into this area activates the Service Monitor mode of operation Other than being 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 ex...

Page 129: ...essed by Beckman Coulter personnel CAUTION Changes to the information in this area should only be done at the request or at the direction of Beckman Coulter Inc Entry of incorrect information will lead to system errors Version Upgrade Introduction The Version Upgrade option allows the operator to load a new version of operating software onto the system Setup From the Setup screen scroll down and s...

Page 130: ...p notes requiring operator attention disabling the alarm will not sound an audible alert Chemistry Update Introduction The Chemistry Update option allows the operator to load a new version of chemistry database software that Updates chemistries on the existing menu Adds new chemistries Setup From the Setup screen scroll down and select 27 Chem Update to load a new version of chemistry database sof...

Page 131: ...ultiple Cartridge option is available With the Multiple Cartridge option enabled the system automatically runs all cartridges on board and runnable for any chemistries for an Auto Generated control Enabling Multiple Cartridge without Auto Generation has no effect on the manual programming of control samples Setup From the Setup screen scroll down and select 29 Auto Generation of Control to enable ...

Page 132: ...A13914AF 3 34 System Setup Options Auto Generation of Control ...

Page 133: ...ompartments include a majority of chemistries excluding the electrolytes include user defined reagents Modular reagents Modular 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 CTS Auto Gloss used to lubricate CTS blade Wash Concentrate II Alkaline Buffer No Foam CTS Auto Gloss and Wash Concen...

Page 134: ...equests can be made simultaneously or independently for the MC and CC sides of the instrument To load MC reagents the system must be in Standby CC reagents can be loaded 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 4 1 Table 4 1 Reagent Status Messages Message Explanation Load...

Page 135: ...op for multiple carts of the same Chem Days Left onboard stability or expiration date whichever comes first Tests Left number of tests left in cartridge Cal Time Left oldest Cal date listed first NOTE The option selected is shown in ascending or alphabetical order When the sorting option is selected the sorting order is retained until the operator changes it Level Pending Reagent cartridge has bee...

Page 136: ...agent Information Reagent information is encoded on the label and read by the bar code reader when the reagent is loaded or unloaded from the system This information makes each container unique and allows the DxC to maintain an accurate inventory of MC reagents Modular Chemistry MC Reagents The Modular Chemistries MC reagents are stored in either 500 mL 1 L or 2 L bottles Refer to Figures 4 3 4 4 ...

Page 137: ... 4 Figure 4 3 DxC 800 Leftmost Compartment Figure 4 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 ...

Page 138: ...mes the bottle is 100 full If the new bottle is not 100 full the volume may be adjusted Load Unload Modular Chemistries MC 1 Select Rgts Cal from the menu bar 2 Select the MC Rgts Modular Chemistries 3 Select Load F1 4 Open the leftmost and or center doors to access modular reagents Refer to Figure 4 3 or Figure 4 4 and Figure 4 5 5 Remove the reagent from the system It is not necessary to scan th...

Page 139: ...nector 3 at side of container NOTE The connector may be located on either side of the No Foam container Using the No Foam Container Cap Wrench loosen the cap 4 from top of lid 1 by turning the wrench counterclockwise NOTE Make sure the wrench is flush with the No Foam cap Using the hand held bar code reader scan the bar code on new No Foam bottle Pour bottle contents into No Foam container 2 Wipe ...

Page 140: ...ies calibrate and run QC before processing patient samples CC Reagents Information DxC Systems use the cartridge bar code to identify and record data regarding reagent name lot number expiration date for example 200601 and serial number of the cartridge Refer to Figure 4 7 and Figure 4 8 Additionally the system retains calibration status of loaded and unloaded cartridges Reagents can be loaded whi...

Page 141: ...oad is positioned on either the upper or lower reagent carousel A blinking bar code reader indicates which carousel position to unload from the upper and lower reagent carousel Top positions 2 are 31 to 59 Bottom positions 3 are 1 to 30 Grasp the cartridge at top and bottom lift up a little and pull back Refer to Figure 4 9 As the cartridge is moved in front of the bar code reader a beep will indi...

Page 142: ...ousel door 7 If multiple positions are selected to load or unload repeat Step 4 6 8 Before processing samples calibrate and run QC if needed Reagent Parameters Calibration parameters specific for a particular reagent lot are included with certain multipoint non linear reagent cartridges These parameters are referred to as Reagent Lot Specific Parameters The Reagent Lot Specific Parameters containe...

Page 143: ...ter data for cartridges that require parameter entry To automatically load reagent parameters Use the hand held bar code reader to scan each of the four bar codes The blue bar indicator on the number button indicates the parameter was scanned successfully Unacceptable bar codes are not read and a message appears 4 To manually load reagent parameters Type the parameterinformation from theparameterc...

Page 144: ...procedures as defined in CHAPTER 9 Maintenance of this manual are performed Calibration options are identified in the Cal Options box To access a cal option select Options F6 from the Reagent Status screen as shown in Figure 4 1 Then select the pull down menu in the Cal Options box to select the desired cal option The cal options are Load calibrator diskettes Calibrator acceptance limits Modify se...

Page 145: ... calibrator bottle Insert the diskette into the disk drive Select OK 6 Verify that the lot number on the screen is the same as the lot number on the calibrator bottle 7 Remove the diskette from the disk drive If no other diskettes are to be loaded Select Cancel If additional calibrator diskettes need to be loaded Select OK and repeat Step 5 If the incorrect diskette was placed in the disk drive Se...

Page 146: ...rs 7 When calibration assignment is complete select Close Calibration Status Introduction Calibration status as well as reagent status is accessed from the Rgts Cal dialog box Calibration status is shown to determine which chemistries require calibration Calibration Status Messages Table 4 2 Calibration Status Messages Message Explanation Requested Indicates that calibration is pending and calibra...

Page 147: ...imits Cal Timed Out Indicates time remaining has exceeded the recommended calibration period Cal Time Extended Operator initiated indicates that the recommended calibration period has been extended The chemistry must have a valid current calibration to be extended Within Lot Pending Indicates calibration has been requested for another cartridge with the same lot number Applies only to chemistries ...

Page 148: ... calibrator bottle agrees with the lot number seen on the screen 5 Place a calibrator bar code label with the name of the calibrator to be used on a 16 mm transport tube Repeat for all calibrators Make sure the correct bar code labels are in the correct positions 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 ...

Page 149: ...which chemistries require calibration 1 Select Rgts Cal from the menu bar 2 Select the chemistries 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 is the same as the lot number on the screen 5 Get the assigned calibrator racks listed on the scree...

Page 150: ...e calibration is not yet in progress Calibrationreports fora given calibrator do not print untilallcalibrations arecompleteforeach chemistry requested unlike sample and control results which print on a cup by cup basis Calibration Failure Messages Introduction If thereisa failureduringcalibration formodular chemistry MC orcartridgechemistry CC there is a pop up message which shows The chemistry th...

Page 151: ...than 8 hours on board the instrument is stored and applied to subsequently loaded cartridges of the same lot Within Lot Calibration Frequency The length of time a within lot calibration factor remains valid its within lot calibration frequency depends on the chemistry During this interval any newly loaded cartridge with the same lot number will receive the calibration status Calibrated At the end ...

Page 152: ... option for the selected chemistry OR Select Cancel to exit without enabling Figure 4 11 Within Lot Calibration Dialog Box NOTE If the within lot calibration mode is disabled any existing cartridges that are using the within lot calibration factor will retain that factor until the cartridge is depleted or until another calibration is requested When a chemistry is deselected the following message a...

Page 153: ... a desired Configured Chemistry name from the Within Lot Calibration dialog box Refer to Figure 4 11 2 Select Status The within lot chemistries appear by the within lot calibration time remaining the oldest calibration date listed first The lot number and the serial number of the cartridges are shown 3 Select Close to exit the pop up window and return to the Within Lot Calibration screen Figure 4 ...

Page 154: ...as established more than 8 hours have lapsed since it was first loaded onto the system ws Reagent has been enabled for within lot calibration but is a stand alone the calibration factor currently used applies only to this cartridge A reagent receives this designation if the cartridge was loaded before the within lot calibration function was turned on more than 8 hours have lapsed since the cartrid...

Page 155: ... used like a calibrator The feature can be turned on or off for applicable chemistries the default is off The Enzyme Validator Kit includes diskettes which provide set points for the selective enzymes IMPORTANT When the enzyme reagent is configured and loaded and the Enzyme Validator feature turns on Enzyme Validator ID assignments and calibration requests can be performed in the same manner as an...

Page 156: ...ing IMPORTANT Overriding a calibration is not usually justified However there may be an emergency situation when a delay caused by calibration is unacceptable to the laboratory The magnitude of error which is deemed acceptable when overriding a failed calibration is totally under the control of the laboratory Therefore the Override function should be used with caution Override a Calibration 1 Sele...

Page 157: ...passed while the system status is Standby 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 Bypass a Chemistry 1 Select Rgts Cal from the menu bar 2 Select the Chem position to bypass 3 Selec...

Page 158: ...yet timed out Extend 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 Extend Calibration Time 1 Select Rgts Cal from the menu bar 2 Select Chem position to extend 3 Select Options F6 4 Select Extend calibration time from the pull ...

Page 159: ...m computer error flags are generated Calibration Acceptance provides a reference to the acceptable limits for calibration View Calibrator Acceptance Limits 1 Select Rgts Cal from the menu bar 2 Select Options F6 3 Select Calibrator acceptance limits from the pull down menu Chemistries appear with chemistry name setpoint value s and appropriate limits 4 Select Next or Prev to locate the calibrator ...

Page 160: ...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 therefore the Set Point Modification ...

Page 161: ...he default values 6 Select Close to exit the screen Calibration status changes to Cal Required A flag indicating that specific set points have been modified will appear in the Instrument Code section on the results report Slope Offset Adjustment Introduction The Slope Offset Adjustment option allows adjustment of the slope m or the y intercept offset b of the regression equation used for results c...

Page 162: ...alues and other method values as x values A minimum of 40 patient samples is recommended From this analysis the regression equation in the following form is obtained To obtain the desired slope and offset values for entry into the Slope Offset Adjustment screen the equation above must be rearranged as follows The Synchron values need to be multiplied by the slope value and then the offset value is...

Page 163: ... Defaults 5 Select Close to exit screen Reprint Calibration Reports Introduction The five most recent calibration reports for a given calibrator chem position may be printed for an historical perspective Reprint Current Calibration Reports 1 Select Rgts Cal from the menu bar 2 Select the chem position s to print NOTE When requesting reports of recent MC calibrations select only one chemistry per r...

Page 164: ... Configured Chemistry name s from the Previous cal report s dialog box NOTE When requesting reports of recent MC calibrations select only one chemistry per report format This prevents duplicate copies For example if NA is selected the report contains all five ISE chemistries 6 Select Add to move the chosen Chemistry ies to the Selected Chemistries area then select OK 7 Select 1 2 3 4 or 5 most rec...

Page 165: ...ERNAL QUALITY CONTROL TESTING PRINCIPLES AND DEFINITIONS Quality Control Program The system Quality Control program provides the capability of monitoring system and chemistry performance by 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 reliabi...

Page 166: ...s 3SD on the QC Log report appears in red on the QC LOG and QC CHART screens is included in a real time pop up window as the system is running 2 2S and R 4S Results Between 2 SD and 3 SD as Compared to the Previous 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 as...

Page 167: ...performance Refer to Figure 5 1 4 1S Within or Across Last Four Results of One or Two Levels of Control Were More than 1 SD From the Mean on the Same Side This rule judges the result out of control if the last four results from 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...

Page 168: ... SD and constituent codes Special or Unique Control Samples Only compatible chemistries should be defined together in the same control definition Pre treated samples for example IBCT diluted samples or samples of different sample types should be defined as separate controls Control Description All described fields of the control definition screen Define Edit Controls must be filled in before leavi...

Page 169: ...Index is applicable to your control material select the Serum Index check box For additional information on serum index refer to the Synchron Clinical Systems Chemistry Reference Manual 7 Select or cursor to the Sample type field Select the pull down menu next to the Sample type field and select the sample type The following sample types are available Serum CSF Plasma Random Urine and Other If a s...

Page 170: ... If returning to the definition screen verify that all of the following definition fields have been filled for any control or requested chemistry Control Name Control Lot Number QC File Number Delete Controls from Definition Screen Selecting the Delete F3 key deletes all definitions for the current control definition Field Description QC File Number Type a QC file number for each chemistry The QC ...

Page 171: ...e between fields When creating Control Bar Code IDs use a format that is distinctly different from Sample IDs This will prevent the reporting of erroneous results due to Controls being run as patient samples or patient samples being run as controls Example Control Bar Code ID SYNCHRON01 Sample Bar Code ID 0000001 3 Select OK to exit the screen and save the bar code IDs OR Select Cancel to clear al...

Page 172: ...s chemistries that are Defined for the control Loaded and calibrated Contain sufficient volume to run the controls 4 If all tests programmed for an Auto Generated control ID do not complete testing for example reagent not onboard calibration required cal time exceeded or disabled the next time the control ID is loaded all tests for the control will Auto Generate and be run again If a control ID th...

Page 173: ...he desired cartridges and select OK 7 Select Save F10 to save the control programming and return to the Program Sample screen IMPORTANT If all tests programmed for the control do not complete testing for example calibration required cal time exceeded or disabled the next time the control ID is loaded only the incomplete tests will run To run all chemistries autogeneration of control the control ID...

Page 174: ... change was made to the mean SD or constituent code the change is reflected in the Define Review screens If changes were not saved the previously defined mean SD are shown NOTE If the assigned mean and SD were modified and the existing data points were not deleted all previous flagging will remain based on original assigned mean and SD 7 Exit the Define Edit Control dialog box by selecting Done F1...

Page 175: ...exit without changing the chemistry selection 4 Select Done F10 to leave the definition screen and to save the control 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 Display QC File Lists in this chapter to ob...

Page 176: ...g serum indices Control ID F2 can be accessed to view the eight bar code IDs Delete F3 can be used to clear a control Select Print F9 to print a control When reviewing QC definition no cursor will be available because changes are not allowed 4 Exit the Review screen by selecting Done F10 Delete a Control Introduction Previously defined controls may be deleted and removed from the system Clearing Q...

Page 177: ...trol will be deleted Archiving is suggested Delete this control Select OK to delete the control OR Select Cancel to retain the control information 5 If the control was deleted type an operator ID of 1 to 3 alphanumeric characters and press Enter Print QC Ranges The entire database of controls may be printed 1 Select QC from the menu bar 2 Select the control to be printed 3 Select Print F10 4 To pr...

Page 178: ...o Define a Control in this chapter A control can be associated with one or more QC files Display QC File Lists 1 Select QC from the menu bar 2 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 in ascending order Use the scroll bar to view additional file number...

Page 179: ... Laboratory QC Summary access Report Setup through System Setup Accessing the QC Summary 1 Select QC from the menu bar 2 A list of currently defined controls appears Select the control for the QC Summary If necessary use the scroll bar to view additional controls 3 Select Summary F6 4 Type a Start date and an End date using the dd mm yy format The default Start End date is the current date Press T...

Page 180: ...odified flag color will not change QC Chart retrieves only the 4000 most recent results within the date range specified If more than 4000 results are within the date range the system does not print the oldest results You may need to specify another date range to retireve the additional results Accessing QC Charts 1 Select QC from the menu bar 2 From the QC screen select a currently defined control...

Page 181: ... 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 appear in the order of the control chemistry configuration 7 Sel...

Page 182: ...based on assigned mean and or SD at time of run If assigned mean and or SD are modified flag color will not change QC Log retrieves only the 4000 most recent results within the date range specified If more than 4000 results are within the date range the system does not print the oldest results You may need to specify another date range to retireve the additional results Accessing QC Logs 1 Select ...

Page 183: ...croll bar to access additional data Data are shown as follows Data points 2 SD appear in yellow Data Points 3 SD appear in red Data Points 2 SD with Precision or Accuracy flags appear in red For a description of how accuracy and precision are determined refer to Accuracy and Precision Flags in this chapter Delete a Data Point IMPORTANT QC data points should only be deleted when the system is in St...

Page 184: ... feature is not available for external media however it is not grayed out If the feature is selected for external media no error message shows Add a QC Action Log Comment 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 ...

Page 185: ... data transfer OR be sure that the data on a previously used diskette has already been uploaded to the Beckman Coulter website NOTE You can store multiple files created from the same analyzer OR files created from multiple analyzers on the same diskette provided that the files are created on the SAME day Otherwise the data will be deleted Data from multiple analyzers will be identified by instrume...

Page 186: ... 5 inch diskette into the console disk drive IMPORTANT A message will display if an error occurs with the diskette Be sure to use a DOS formatted 3 5 inch diskette 10 Select OK to continue OR Select Cancel to return to the QC Summary screen 11 If the diskette copy is successful the following message appears QAP diskette creation complete Select OK to exit this screen 12 Select DONE F10 13 If neces...

Page 187: ... the oldest result related to the new result will be overwritten If the QC Results database is full and no results are associated with the QC 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 Archive QC IMPORTANT To archive Current QC Da...

Page 188: ...perator selects 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 Review Archived Data Introduction Archived data can be reviewed from a diskette Review options available from the floppy include review of demographics and cumulative statistics for a contr...

Page 189: ...e next diskette Review the information shown and Select OK or Cancel accordingly as described above 6 Select External Media from the QC dialog box Diskette retrieval provides access to date review of Control Ranges QC Log QC Summary and QC Chart No modification to the data is allowed 7 Select any of the following options Review F1 to review archived control definition List F4 to view and Print arc...

Page 190: ...A13914AF 5 26 Quality Control Review Archived Data ...

Page 191: ...cause an INCOMPLETE status for the Sample ID Samples may be described and defined through use of the Sample 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 des...

Page 192: ...d with tests from incomplete samples that previously used that ID In addition patient demographics at the instrument are from the previous use of the sample ID Since demographics are not uploaded from the instrument it is possible for these merged results to be uploaded to the LIS which would contain the current demographics Figure 6 1 Program Sample Screen Prior to Programming Introduction Prior ...

Page 193: ...lly assigned samples or controls need to be cleared from racks 1 Select Samples 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 6 1 for a description of each Sample Status Press Page Up or Page Down to view additional rack numbers 4 The following functions are available To clear a rack or several racks Select...

Page 194: ... Sample ID assignment is required but both can be entered Refer to CHAPTER 3 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 is offloaded and ...

Page 195: ...S 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 are merged with tests from incomplete samples that previously used that ID I...

Page 196: ...ogramming must be cleared 1 Load tubes in a rack with the bar code labels visible through the slot on the same side of the rack as 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 cap with a cotton tipped applicator stick For non CTS Systems or tubes not validated for closed tube sampling remove th...

Page 197: ...e the desired manual assignment into the selected rack position 5 Select OK to accept the assignment OR Select Cancel to leave assignment screen without saving assignments 6 Select Program F10 to return to Sample Program screen Processing Samples Manually Manual programming is used when there is no LIS or the LIS is not available Samples may or may not be bar coded The sample is identified by a Sa...

Page 198: ...and Pos fields 3 If the sample is stat select the STAT check box 4 Select Sample Type from the pull down menu NOTE The sample type for UDR must be serum plasma CSF or urine Do not use any other sample type 5 Select Sample Comment from the pull down menu 6 To enter Demographics select Demog F2 Type the information provided and select Next F10 to return to the Program Sample screen 7 Select each che...

Page 199: ...6 3 Type the sample ID rack 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 Select All previous programming is highlighted Deselect chemistries that are not to be run Select Save F10 to accept programming and exit screen To rerun all completed tests press All 5 For a Routine Sample or if system...

Page 200: ...sult generated by the system is multiplied by the factor NOTE The dilution factor will remain as part of the sample programming and must be removed if performing additional testing of the undiluted sample Programming a Manual 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 concentrat...

Page 201: ...n End Batch is requested or upon exiting the Sample Program screen Batch programming in rack and position mode can be performed using the following procedure 1 Select Samples 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 A list of available racks for batch programming appears Ra...

Page 202: ...ecall function using the appropriate recall option Calibrator IDs or rack position assignments are not cleared from within Sample Programming Refer to CHAPTER 4 Reagent Load Calibration Calibrator Assignment for information on calibrator identification IMPORTANT When clearing data to verify exactly what will be cleared first view the load list for the intended range of samples The samples recalled...

Page 203: ... the two depending on the type of sample ID entered These same methods of retrieval are used for Load List Clear Samples and Recall Sample IDs containing only Numeric Data Samples are listed in numeric order For example 1 2 3 4 Include leading zeros in the Range field For example range 1 thru 1000 would not include sample 0099 but range 0001 thru 1000 would Sample IDs containing only Alpha or Alph...

Page 204: ...D was located 4 Select OK to continue clearing A confirmation screen appears OR Select Cancel to retain sample programs Deletion Criteria Procedure for Sample Clearing Sample ID Type 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 Sam...

Page 205: ...ults 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 is available for recall only after the system begins to run the new assignment CAUTION If a ...

Page 206: ... from the menu bar 2 To input an individual Sample ID Type the Sample ID desired for recall in the Sample ID field To input a range of Sample IDs Type the Sample ID at the beginning of the range in the From field Press Tab Type the Sample ID at the end of the range in the To field Press Enter To input select a function button from the bottom of the screen to select a desired output option Results ...

Page 207: ... by a comma to define a series and or by a dash to define a range If one rack number and no position number is entered all positions on the rack are automatically selected If more than one rack number is entered All positions on each rack are automatically selected The Pos s field cannot be accessed 3 Select a function button from the bottom of the screen to select a desired output option Results ...

Page 208: ...lts 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 Recall Results by Run Date Time 1 Select Results from the menu bar 2 From the Recall Results By dialog box type the desired date and time ranges in the From fields and To fields 3 Select a function button from the bottom of the screen to select a desired output...

Page 209: ...ce versus Time plot OR Select Edit F4 to edit OR Select Host F6 to send results to the host OR Select Print F7 to print OR Select Prev F8 to view a previously shown sample OR Select Next F9 to view other samples if more than one sample was recalled OR Select Done F10 when done Table 7 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 ...

Page 210: ...etation only a rate and a critical rerun remark are shown Use the printed report to compare the two interpretations If they are both positive or both negative delete the second result Delete Critical Rerun Result Follow the steps below to delete one of the two results of a sample which was rerun with Critical Rerun Result 1 From the Recall Results By dialog box select the results to be viewed as p...

Page 211: ...ample OR Select Next F9 to view other samples if more than one sample was recalled OR Select Done F10 when completed Print Recalled Results All recalled results may be printed 1 Select Results from the menu bar 2 To print using the default report format Go to Step 4 To print using Patient Multi Sample report format Continue with Step 3 3 If Patient Multi Sample Report box is selected input specifi...

Page 212: ...Recall and send whole groups of data Recall and send individual sample data Send Data 1 Select Results from the menu bar 2 To send whole groups of data Type the range of racks Sample ID patient ID or run date time Select Host F8 To send individual sample data Type the Sample ID patient ID run date time or racks position Select Host F8 Absorbance Versus Time To get data to help troubleshoot complet...

Page 213: ...row To see the Absorbance vs Time Table Select the Table tab 5 To output a file to a diskette Select Done to exit the screen Select Disk F1 To output Absorbance vs Time Plot and Absorbance vs Time Table to a printer Select Both To output either Absorbance vs Time Plot or Absorbance vs Time Table to a printer depending on which is on the screen Use the Plot or Table tab at top of screen to go from ...

Page 214: ...tion 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 Display Statistical Summary 1 Select Results from the menu bar 2 Type the range of desired results use any of the Results Recall criteria described in the Send Results to the Host section ...

Page 215: ...s may be used with these configured chemistries In addition up to 10 of the 100 user defined chemistries may be configured with the Expanded User Defined Chemistry feature Refer to the end of this chapter for further information NOTE The sample type for UDR must be serum plasma CSF or urine Do not use any other sample type Requirements and Precautions Minimum Requirements for Operation The followi...

Page 216: ...or the frequency thereof or their effect on operator safety User assumes full responsibility for use of the proper test protocol and test result generation for the reagent s selected by the user and for any errors or omissions associated therewith BECKMAN COULTER EXPRESSLY DISCLAIMS ALL WARRANTIES WITH RESPECT TO THIS PRODUCT WHETHER EXPRESS OR IMPLIED INCLUDING WARRANTIES OF MERCHANTABILITY OR FI...

Page 217: ...Define F1 5 Type information for the user defined reagent as defined on the following screens Chemistry Parameters Processing Parameters Error Detection Limits 6 Select Restore F1 to restore the default parameters OR Select Cancel F9 to cancel and return to previous screen OR Select Done F10 to save and exit If an area is incomplete or incorrect a flag appears indicating the error Perform the appr...

Page 218: ...urement in the UniCel DxC Synchron Clinical Systems Reference Manual for a detailed explanation of each type Table 8 2 Allowable Entries for a Chemistry Test Name A maximum of four alphanumeric characters including The first character MUST be an alphabetical character Table 8 3 Reaction Type Options Reaction Type Description Endpoint 1 Blank absorbance is not subtracted from Reaction 1 absorbance ...

Page 219: ...bsorbance with time A negative reaction direction indicates decreasing absorbance with time Table 8 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 GHb 46 AU L 7 mEq L 17 other 27 Ku...

Page 220: ...and secondary wavelength cannot be equal Table 8 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 logit function DAT Math Model Double Inflection Model DP4 Table 8 8 Options...

Page 221: ...n two calibrators A non linear math model requires five or more calibrators If two or more calibrators are used span values are shown If five or more calibrators are used recovery and sensitivity statistics are also shown where e1 The extinction coefficient of the chromophore at the primary wavelength e2 The extinction coefficient of the chromophore at the secondary wavelength Extinction coefficie...

Page 222: ...s is zero Refer to CHAPTER 4 Reagent Load Calibration for calibration procedures IMPORTANT If the UDR is removed from the instrument calibration is lost To enable Cal Save refer to Expanded User Defined Chemistry Feature in this chapter Processing Parameters First Inject Component The First Inject component designates the compartment of the cartridge which will be pipetted first First Inject Dispe...

Page 223: ...a minimum of 8 seconds after sample has been pipetted Time is entered in increments of 1 second however the reagent is 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 dispenses reagent at the same time as First Inject reagent component IMPOR...

Page 224: ... default compartment selection is None and should not be modified 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 Table 8 19 Options for the Third Inject Componen...

Page 225: ...r than Second Inject add time Sample Volume Total volume of sample and reagents A B and C cannot exceed 330 μL Volume is specified in increments of 1 μL Blank Read Times Blank read times indicate when the blank absorbance is to be read Time 180 to 1 is a reagent blank Time 1 is when sample is added to the cuvette Time 1 to 720 is a sample blank Time is entered in 1 second intervals but readings be...

Page 226: ...e N The initial read starts at cycle N and ends at cycle N 1 Reaction Read Times Reaction read times indicate when the reaction is to be read Time 1 is when sample has been added to the cuvette Time is entered in 1 second intervals but readings begin at the next 8 second interval Table 8 24 Initial Read Times Allowable Entry Start Read 1 to 1704 seconds End Read 9 to 1720 seconds Table 8 25 Reacti...

Page 227: ...ged as blank absorbance rate high BL ABS HI or BL RATE HI or blank absorbance rate low BL ABS LO or BL RATE LO Mean deviation is a measure of noise in the read window Reaction Absorbance or Rate Reaction specifies the minimum and maximum 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 Lo...

Page 228: ...t 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 are only shown for the number of calibrators specified under of Calibrators A change in calibrator number resets the spans to zero 0 000 The sign positive or negative of multipoint spans are dependent upon the d...

Page 229: ...Operation in the UniCel DxC Synchron Clinical Systems Reference Manual Secondary Wavelength Selection To select the optimal secondary wavelength for a given analyte the following criteria are recommended The secondary wavelength should be as close to the primary wavelength as possible without overlapping the spectral curve of the desired chromophore The secondary reference wavelength should be nea...

Page 230: ...tion Coefficients Introduction In general there are two ways to determine the molar absorptivity or extinction coefficient e for a given chemistry at each of the wavelengths required for analysis Option 1 Prepare a stock standard solution of the chromophore From this stock solution prepare a working standard solution at the same molar concentration recommended by the reagent manufacturer Obtain ab...

Page 231: ...ectness completeness and consistency Chemistry protocols that fail any Exit Check criteria are not allowed to run The following requirements specify the Exit Check criteria and parameters presented for modification when the user elects to correct detected protocol errors Wavelengths The primary wavelength must not be None The secondary wavelength must not be None The primary wavelength must be dif...

Page 232: ... rate low limit cannot exceed the high limit for positive reaction direction chemistries The rate low limit must exceed the high limit for negative reaction direction chemistries Measurement The reaction end read time must exceed the reaction start read time by a minimum of one processing cycle The reaction absorbance high limit must be greater than the reaction absorbance low limit The usable ran...

Page 233: ...cartridge from system 2 Delete UDR information from the following areas reference ranges calibration assignments sample programming and quality control 3 Select Setup from the menu bar 4 Select 2 Chem Config Sample Type 5 Select the chemistry to be deleted 6 Select Delete F6 to remove the UDR from the chemistry menu 7 Select Setup from the menu bar 8 Select 15 User Defined Chemistries 9 Select the...

Page 234: ...n UDR F3 is selected from the Define Edit User Defined Chemistry screen An Expanded UDR chemistry is denoted by a placed in front of the UDR name when viewed in the User Defined Chemistries screen Cal Save Cal Save allows the calibration parameters to be retained when the cartridge is removed from the instrument When the cartridge is reloaded within the calibration time limit recalibration is not ...

Page 235: ...RDAC can be turned on for automatic use through System Setup or manually requested in the Sample Program Enable Disable UDR ORDAC 1 The instrument must be in Standby or Stopped mode 2 Select Setup from the menu bar 3 Select 15 User Defined Chemistries 4 Select the number to be defined OR Type a number in the Option Number field 5 Select Define F1 6 Select UDR F3 7 Go to page 2 of the UDR Setup typ...

Page 236: ...n the UDR cartridge Enable Disable On Board Dilution 1 The instrument must be in Standby or Stopped mode 2 Select Setup from the menu bar 3 Select 15 User Defined Chemistries 4 Select the number to be defined OR Type a number in the Option Number field 5 Select Define F1 6 Select UDR F3 7 Go to page 2 of the UDR Setup and select Dilute F2 A new window appears 8 Type the volume of neat sample to us...

Page 237: ... be adjusted 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 11 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 shou...

Page 238: ...me autoprime and return the system to Standby Common Abbreviations CC Cartridge Chemistry side of the system MC Modular Chemistry side of the system ISE Ion Selective Electrode Flow Cell Module EIC Electrolyte Injection Cup CCWA Cartridge Chemistry Wash Solution CTS Closed Tube Sampling Maintenance Schedule CAUTION If the DxC is connected to the automation line make sure the DxC is in Manual mode ...

Page 239: ... and Albumin Cups DxC 800 only Clean Probes Exterior Clean Flow Cell Cups and CC Probes Mixers Automated This weekly maintenance is superceded by the mandatory Twice Weekly procedure Clean Sample and Reagent Probes Mixers EIC and Flow Cell Check Chloride Calibration Span Monthly Maintenance Replace Alkaline Buffer Clean All Cup Modules Clean Mixers Calibrate Lamps and Sensor BUNm UREAm Electrode M...

Page 240: ...at does not have Closed Tube Sampling CTS hardware does not show the maintenance items for that hardware On the Scheduled Maintenance Log screen these groups have been placed under separate tabs labeled Weekly Monthly Two Month Three Month Four Month Six Month To identify the maintenance procedures that are DUE follow the yellow highlights as listed below Select Utils from the menu bar Select 2 Ma...

Page 241: ...d typing the information using the keyboard Press Enter to save the data The tabs and available functions of the Scheduled Maintenance Log feature are described below Help On line Help is available through the Scheduled Maintenance Log feature and Automated Maintenance Procedures Select the Help icon next to the maintenance procedure to display specific information about the procedure If the Help ...

Page 242: ...nth maintenance you must enter a sensor electrode number Record the number found on the sensor or electrode before you install it Date Performed Field Shows the date entered by the operator on which the maintenance was performed Initials Field Shows the initials entered by the operator of the person who performed the maintenance Days Left Field Shows the number of days left until a maintenance pro...

Page 243: ...his option exits the Scheduled Maintenance Log feature and returns the operator to the Maintenance screen Twice Weekly Maintenance Introduction Perform Twice Weekly Maintenance on the same days each week These procedures prevent contamination build up on the instrument Clean Sample and Reagent Probes Mixers EIC and Flow Cell Clean the MC Sample Probe CC Sample Probe Reagent Probes and Mixers EIC a...

Page 244: ...ct Samples from the menu bar NOTE Disable Serum Index to continue with this cleaning procedure 3 In the Program Sample screen Enter a rack number and press Enter Enter a position number and press Enter Enter a Sample ID optional 4 Select any one of the ISE chemistries for example K for diluted Clenz Solution Sodium Hypochlorite and Saline 5 Select Options F3 6 Enter the required number of replicat...

Page 245: ...t Action F1 Record the Twice Weekly maintenance and press Save 13 To remove the yellow highlight from the maintenance icon select the Initial and Date checkbox for both the Clean Flow Cell and Cups and the CC Probe Cleaning procedures under the weekly maintenance tab in the electronic maintenance log To complete the entry of this information select the Initial and Date button When a procedure has ...

Page 246: ... 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 A pop up message appears when approximately 10 and 5 of an MC reagent remains 6 If necessary load a new bottle of reagent Be careful whe...

Page 247: ...over being careful not to disturb the CC sample mixer Figure 9 2 Cuvette Wash Station Cover 2 Loosen the two thumbscrews 1 on each side of the cuvette washer Lift off the upper section of the cuvette wash assembly Pull off the silicone wiper Figure 9 3 3 Install new wiper 1 by sliding it onto the bottom of the probe until the under surface of the wiper is flush with the end of the probe ...

Page 248: ...o may cause a flood 6 Reinstall the cuvette wash station cover Clean Total Protein and Albumin Cup Modules DxC 800 Only Total Protein and Albumin modular reaction cups and stir bars should be cleaned weekly or more frequently if the chemistry does not calibrate or when chemistry performance indicates IMPORTANT For convenience the Total Protein and Albumin Cup Maintenance procedure is also included...

Page 249: ...in cup 4 Let the cleaning solution sit in the cups for 10 minutes The stir bars continues to stir during this time 5 At the end of the 10 minute waiting period select Close to exit the Result pop up window 6 Select Rinse The cups are drained and rinsed 5 times with water 7 When the Rinse procedure is complete select Close to exit the Result pop up window then select Drain 8 When the Drain procedur...

Page 250: ...r probe area CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when you perform this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter 1 Press the STOP button on the instrument to place the system into Stopped state The probes are ready for manual maintenance when system status is Stopped 2 Wipe the out...

Page 251: ...1 Press the probe down into the depression Wipe the outside portion of the exposed probe Figure 9 5 4 To access the lower portions of the MC and CC sample probes under the attached wash collars remove the sample carousel cover To continue access Move the sample probes to a clear space 1 between the sample carousel racks and the sample carousel tub Press the probe down into the clear area Wipe the ...

Page 252: ... Solution freshly prepared by adding 4 drops of Clenz Solution PN 664090 to an empty 2 mL sample cup Fill to 2 mL line with 0 9 saline and mix 2 mL sample cup of 0 9 saline required for CC Probes Mixers CCWA cartridge PN 657133 required for CC Probes Mixers CCWA must have at least 25 tests available Cleaning Procedure 1 Load CCWA cartridge 2 Select Utils from the menu bar 3 Select 2 Maintenance 4 ...

Page 253: ... the bottom of the page If the value is 1800 replace the electrode tip when it is convenient to your work load See Replace the Chloride Electrode Monthly Maintenance Replace Alkaline Buffer Adjust the Fluid Level of the Alkaline Buffer Damper Assembly Clean All Cup Modules BUNm UREAm Electrode Maintenance DxC 800 Only Calibrate Lamps and Sensor Clean Mixers Replace CTS Blade 1 Blade Narrow CTS Opt...

Page 254: ...r a container that catchs the residual fluid from the alkaline buffer return line 33 4 Prime the line 10 times Select Utils from the menu bar 1 Prime MC F4 ISE CO2 Alkaline Buffer Type 10 in the Number of primes to repeat field Select Start Prime Reagent line is drained of old reagent 5 Remove reagent input line 30 1 line draining into damper from the top of the in line filter ...

Page 255: ...put 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 Rgts Cal from the menu bar MC Rgts Load F1 ...

Page 256: ...ent Load Calibration in this manual 11 Select Done F10 when finished 12 While priming with the alkaline buffer reagent check the peri pump tubing and line for leaks or other problems Correct as needed 13 Adjust the fluid level of the Alkaline Buffer Damper Assembly Refer to the Adjust the Fluid Level of the Alkaline Buffer Damper Assembly procedure CAUTION Pinch hazard Keep fingers clear of the IS...

Page 257: ...ed to Step 2 If fluid level is above the MAX line go to Step 8 2 Remove the alkaline damper 1 from the holding clip and place the damper in a horizontal position Figure 9 10 NOTE The damper should be positioned so that the output line 29 2 Figure 9 10 leading from the damper to the flow cell is oriented on top 3 Prime alkaline buffer five times or as many times as necessary to fill the damper one ...

Page 258: ...ip the damper assembly back into the upright position CAUTION Pinch hazard Keep fingers clear of the ISE module as you lower it 7 LowertheISE moduleby releasing thelockingpin Becareful NOT to pinch tubing as the module is lowered 8 Reinstall the ISE module cover 9 If the fluid level is above the MAX line Remove input line 30 1 feeding into the damper Using a clean transfer pipette remove excess re...

Page 259: ...tinine and Total Protein cup modules need to be cleaned monthly Prepare the cup modules for cleaning as follows The following procedure can be applied to all modular chemistry cups Where applicable the procedure lists instructions specific for a particular cup It is important to follow any special case instructions It is recommended to prepare all requested cups for maintenance at the same time Ta...

Page 260: ...ng solution to each of the cups BUNm UREAm GLUCm PHOSm and ALBm One mL of 1N 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 continues to stir during this time 5 At the end of the 10 minute waiting period select Close to exit the Result pop up window 6 Select Rinse The cups are drained and rinsed 5 times with water 7 When rins...

Page 261: ...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 indicates that the cup is drained and ready for maintenance 3 Loosen the two Phillips screws on the ISE module cover and remove the cover 4 Loosen the two screws 1 on the MC cover and gently remove the cover Figure 9 12 ...

Page 262: ...crew the BUNm UREAm electrode retainer nut 1 and withdraw the electrode retainer assembly from the chemistry reaction cup Figure 9 14 7 Separate the electrode 3 retainer 2 and retainer nut 1 Refer to Figure 9 15 It is not required to clean the stir bar however the stir bar may be cleaned if desired while the BUNm electrode is removed from the cup Refer to Four Month Maintenance Clean the MC Reagen...

Page 263: ...from the front face of the electrode Refer to Figure 9 15 Figure 9 15 9 Rinse the quad ring in deionized water Dry with a lintless tissue 10 Use a lintless tissue moistened with deionized water to clean the electrode face until the gold surface is bright Rub parallel to the gap 1 with tissue Rinse with deionized water Dry with a lintless tissue 1 Retainer Nut 2 Retainer 3 Electrode 4 Quad Ring ...

Page 264: ...ort 13 Using dry lintless tissue wipe the electrode mounting port 14 Reinstall the quad ring on the face of the electrode 15 Reinstall the retainer and retainer nut on the BUNm UREAm electrode 16 Rotate the electrode until the electrode key enters the retainer keyway and reinstall the retainer nut on the electrode retainer assembly 17 Align the keyway on the body of the retainer containing the ele...

Page 265: ... Maintenance menu If the BUNm UREAm electrode maintenance was performed wait 15 20 minutes to allow for thermal equilibration Calibrate BUNm UREAm To ensure there are no bubbles in the BUNm UREAm cup immediately prior to calibrating wrap the tip of an applicator stick with lintless tissue Insert the end of the stick into the bottom of the cup and carefully swab the electrode 24 Proceed to Calibrat...

Page 266: ...and ends 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 Refer to Six Month Maintenance procedures in this chapter for glucose sensor replacement 7 Select Close to exit the Lamp Sensor Calibration screen 8 Proceed to Reassemble the MC...

Page 267: ...ly to clean any buildup or discoloration that may accumulate over time CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when you perform this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter Gently but thoroughly wipe the outside of both mixers 1 and 2 of Figure 9 17 using 70 isopropyl alcohol and lin...

Page 268: ... Cap Piercer blade is very sharp and has been exposed to potentially biohazardous fluids To prevent injury or exposure do not touch the points of the blade and wear gloves Figure 9 18 Cap Piercer Blade Materials Required Medium straight edge screwdriver Replacement Procedure 1 To access this procedure Select Utils from the menu bar 2 Maintenance 1 CTS Blade Replacement To start the procedure selec...

Page 269: ...sh Tower Avoid the bottom of the Wash Tower CAUTION DO NOT select OK when the cover is removed If you select OK the Cap Piercer Carriage moves up and causes a pinch hazard 3 Fully loosen the two captive Cap Piercer cover screws 1 at the base of the Cap Piercer cover Lift and remove the cover Figure 9 19 A014462P EPS 1 ...

Page 270: ...it 7 Discard the old blade into a biohazard sharps container NOTE The points of the blade are very sharp 8 Remove a new blade from its container 9 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 into place Finger tighten the captive blade s...

Page 271: ...11 Install the Cap Piercer cover and tighten the two captive Cap Piercer cover screws 12 Select OK The system sets the blade count to zero The Cap Piercer carriage moves up to Home position 13 Simulate the load of CTS Auto Gloss Lubricant by clearing and resetting the values on the Auto Gloss screen at Reagent Load Select MC Reagent Load from the screen Select Auto Gloss Select F1 Clear Type XXXXX...

Page 272: ...ick more frequently The blade count records the number of caps pierced by the blade Refer to CHAPTER 10 System Status and Commands CAUTION The Cap Piercer blade is very sharp and has been exposed to potentially biohazardous fluids To prevent injury or exposure do not touch the points of the blade and wear gloves Figure 9 21 Cap Piercer Blade with CTS Auto Gloss Wick Materials Required Medium Phill...

Page 273: ...r blade and wick replacement then the Maintenance pop up confirmation window appears CAUTION The points of the Blade are very sharp and extend below the Wash Tower Avoid the bottom of the Wash Tower CAUTION DO NOT select OK when the cover is removed If you select OK the Cap Piercer Carriage moves up and causes a pinch hazard 3 Fully loosen the two captive Cap Piercer cover screws 1 at the base of ...

Page 274: ...gure 9 23 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 clip 5 Figure 9 23 A015940P EPS 2 3 4 5 1 ...

Page 275: ...d to the blade Do not touch the wick because it contains CTS Auto Gloss lubricant which is very slippery and difficult to clean Discard the old assemblies into a biohazard sharps container Figure 9 24 6 Refer to Figure 9 24 NOTE A new blade is shipped with a wick attached The points of the blade are very sharp The blade shaft is not sharp Remove a new blade and wick from its container Hold it at t...

Page 276: ...h the points of the blade Figure 9 25 8 Refer to Figure 9 23 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 to hit the points of the blade on the edge...

Page 277: ...er compartment doors left middle and right 2 Pull up and remove each of the compartment air filters There are two different sizes of air filters They are located over vent areas on the inner side of each door 3 Vacuum or brush each filter thoroughly to remove dust If excessively dirty rinse with deionized water Vigorously shake residual water from filters Allow the filter to air dry completely CAU...

Page 278: ...to position on each door placing the small filters 1 on top and the large filter 2 on the bottom Refer to Figure 9 26 Slide each filter into position so that the metal grating faces towards the inside of the instrument when the doors are closed Figure 9 26 5 Close all compartment doors ...

Page 279: ... 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 CAUTION To prevent damage due to electrical static discharge ESD wear a wrist ground strap when you perform this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter Figure 9 ...

Page 280: ...activate the automated Syringe Rod Replacement procedure IMPORTANT The system status must be in Standby to access Maintenance mode 1 Select Utils from the menu bar 2 Maintenance 7 Syringe Rod Replacement 2 Select Continue to prepare the syringe rod assemblies for maintenance OR Select Cancel to immediately return to the Maintenance menu without performing syringe rod maintenance 1 MC Sample Syring...

Page 281: ...or placement Figure 9 29 4 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 from the Luer lock fitting Refer to Figure 9 28 5 Unscrew the round plunger end 1 Figure 9 30 A015944P EPS 1 A011874P EPS 1 ...

Page 282: ...amount of air bubbles and insert the tipped end of the plunger rod into the syringe barrel 3 Screw the brown plunger guide onto the barrel finger tight CAUTION When installing the syringes do not mix the two different syringe sizes The MC and CC sample syringes 100 μL are located on the back wall of the instrument The CC reagent syringe 500 μL is located on the right side of the instrument 4 To in...

Page 283: ...ect Close to return to the Maintenance menu Prime the Syringes 1 Prime syringes 10 times Do the following Select Utils from the menu bar Select 1 Prime Select CC F2 Select Reagent and or Sample Delivery Subsystem Type 10 in the Number of primes to repeat field Select MC F4 Select Sample Delivery Subsystem Select Start Prime 2 Check the syringes and aspiration lines for air bubbles If bubbles persi...

Page 284: ...rd 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 compar...

Page 285: ...ely four minutes 5 When priming is complete let the solutions sit in the cups for 10 minutes 6 At the end of the 10 minute period remove straws from the cleaning solution wipe straws dry and insert all straws into the container of deionized water Select Close to exit the pop up confirmation window 7 Select Prime20 The cups are primed 20 times with deionized water 8 When priming is complete remove ...

Page 286: ...emistry calibration To ensure there are no bubbles in the BUNm UREAm cup immediately prior to calibration wrap the tip of an applicator stick with lintless tissue and swab the electrode surface 14 Select the desired chemistries Then select Drain NOTE It is not necessary to select Glucose if the stir bar was cleaned during the glucose sensor replacement CAUTION Remove the Glucose sensor before remo...

Page 287: ...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 17 Reinstall the stir bars in the appropriate cups NOTE Be careful to return the correct size stir bar to its appropriate cup to assure proper stirring movement Replace the stir bar if cracks or burrs are detec...

Page 288: ...in the flow cell The operator may replace one or both electrode tips at the same time Replace the calcium tip at 6 months or 80 000 samples Before you install a calcium or potassium electrode tip into the flow cell record the electrode number found on the tip You must enter this number into the Electronic Maintenance Log at the end of the procedure 1 Pour ISE Reference Solution do not dilute into ...

Page 289: ...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 are not compromised during this time 4 After soaking is completed remove the tip from the soaking solution and dry sides using a lintless tissue DO NOT touch electrode tip 5 Remove the back protective cov...

Page 290: ...e two Phillips screws 1 on the ISE module cover and remove the cover Figure 9 34 2 Release the locking pin 1 on the ISE module and lift the module until it clicks into a raised locked position 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 9 35 ...

Page 291: ...ce Chloride Electrode or Replace the Chloride Electrode Tip CO2 Measuring Electrode Replace the CO2 Membrane Sodium Electrode Replace the Sodium Measure Reference Electrode Removal and Installation of the Electrodes CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when you perform this procedure For further instructions refer to Basic Laboratory Practice...

Page 292: ...l Removal of the flow cell is not necessary for replacing electrodes located on the right side of the flow cell Figure 9 37 3 Locate Potassium electrode 1 Remove electrode by loosening the electrode retaining nut AND OR Locate Calcium electrode 2 Remove electrode by loosening the electrode retaining nut Figure 9 38 4 Remove the retainer nut from the old electrode Remove the quad ring 1 from the ti...

Page 293: ...or proper seating of electrode gently pull on electrode body The electrode assembly should not move If the electrode moves remove it and install it again Check for an extra or missing quad ring if installation is difficult 10 Reposition flow cell on the mounting panel and tighten the one retaining screw Reconnect electrode cable to the appropriate terminal being careful not to bend connecting pin ...

Page 294: ...ium Replace Glucose Sensor The Synchron AccuSense glucose oxygen sensor requires no assembly Each sensor has a gasket positionedover the membrane tip Thesensoris discardedafter six months usageon an instrument at which time a new sensor is installed Before you install the glucose sensor recordthe sensor number found on the sensor You must enter this number into the Electronic Maintenance Log at th...

Page 295: ...age 2 Remove the protective cap from the electrode connector 3 Check the sensor for the presence of the gasket on the membrane tip If the gasket is missing replace it at this time 4 Visually inspect the sensor for leakage or puncture of membrane 5 Hold the sensor in a vertical position with the membrane tip pointed down Tap on the side of the sensor body to remove any bubbles from the membrane tip...

Page 296: ...ime and return the system to Standby 1 Drain the reagent from the MC cup Select Utils from the menu bar 2 Maintenance 4 Cup Maintenance 2 Select Glucose cup to be drained in preparation for maintenance 3 Select Drain This drains the cup of reagent so that maintenance may be performed OR Select Cancel to immediately return to the Maintenance menu without draining the cup 4 Proceed to Sensor Replace...

Page 297: ...sconnect sensor pin lead from connector panel Figure 9 41 3 Unscrew the sensor retainer nut 1 and withdraw the sensor assembly from chemistry reaction cup Verify that the gasket 2 from the removed sensor has not been left in port opening Figure 9 42 4 Separate the sensor from retainer nut Discard the old sensor and gasket ...

Page 298: ...el in a vertical position with the membrane tip pointed downward tap side of sensor body to remove any bubbles from the membrane tip 7 This step 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 connector onto the new sensor 9 Align the keyway on the body of th...

Page 299: ...Clean the EIC Port Clean the CO2 Alkaline Buffer Lines Clean the ISE Drain Flush the Flow Cell Manual Clean the ISE Flow Cell Using Clenz Solution Flush the Sample and Reagent Probe Replace the Sample and Reagent Probe Clean the CC Sample Probe Reagent Probes and Mixers Clean the MC Sample Crane and Collar Assembly Clean the Precipitate in PHOSm DxC 800 Only Inspect the Cuvette Washer Probe Wash A...

Page 300: ...nance Screen includes a free text Action Log function that allows you to create notes regarding maintenanceissues andprocedures To display theMaintenanceAction Log screen select the Utils icon then select 2 Maintenance then Action F1 Usethe Action Log to recordany As Needed or As Required maintenance you perform Replace the Chloride Electrode Tip Prepare the CL electrode tip as follows prior to re...

Page 301: ...ce in the beginning of this chapter 1 Disconnect the electrode cable from the CL connector 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 IMPORTANT Do not disconnect any of the reagent lines attached to the flow cell Removal of the flow cell is not necessary for...

Page 302: ... 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 9 45 5 Unscrew the old tip from the electrode assembly Discard the O ring and the old electrode tip 6 Install a new O ring on chloride electrode tip and screw the tip onto electrode body 7 Completely dry the electrode port with lint free tissue ...

Page 303: ...11 Select OK in the Maintenance pop up confirmation window when the electrode service has been completed and the electrode has been properly replaced IMPORTANT Reagents immediately prime through the flow cell While the system is priming observe the flow cell for leaks Stop the priming if any leaks are noticed and correct the problem 12 When the system has completed priming select Close to exit the...

Page 304: ...ple 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 50 mm 1 Figure 9 46 2 Unpack a new sodium electrode Carefully remove black protective cap covering glass tip IMPORTANT If maximum soaking time is not allowed the new electrode may require a few hours of operation to achieve complete electrical stability During this p...

Page 305: ... below The instrument status must be Standby to perform this procedure CAUTION To prevent damage due to electrical static discharge ESD wear a wrist ground strap when you perform this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter 1 Loosen the two Phillips screws on the ISE Module cover and remove the cover 2 Release the locking pin on the IS...

Page 306: ...ed OR Select Cancel to immediately return to the Maintenance menu without draining the flow cell IMPORTANT Do not disconnect any of the reagent lines attached to the flow cell 5 Disconnect the electrode cable 1 Figure 9 48 6 Loosen the flow cell retaining captive screw 1 located at the top of the flow cell Pull flow cell assembly forward Figure 9 49 ...

Page 307: ...8 Remove the retainer nut from the old electrode and install on new electrode 9 Examine the electrode tip If an air bubble is seen inside the tip hold the electrode cable near the end and spin the electrode for a few seconds The bubble should be pushed back inside the electrode and remain there away from the tip 10 Using a lintless tissue carefully and thoroughly dry the electrode sides and electr...

Page 308: ...move If the electrode moves remove it and try to install it again If installation is difficult check for an extra or missing quad ring 13 Reposition the flow cell on mounting panel and tighten the retaining screws 14 Reconnect the electrode cable to the appropriate connector 15 Select OK in the Maintenance pop up confirmation window 16 Select Close in the Result pop up window Proceed to Prime the ...

Page 309: ...Replace the CO2 Membrane The permeability of the CO2 membrane may change depending on usage and time Changes in the membrane could be caused by a coating build up wear or general deterioration Replace the CO2 membrane as needed whenever these conditions occur CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when you perform this procedure For further ins...

Page 310: ...Maintenance 3 Prepare for ISE maintenance and disable autoprime Select Utils from the menu bar 2 Maintenance 3 ISE Service Continue The flow cell is prepared for maintenance 4 Disconnect the CO2 Measuring Electrode cable 1 Figure 9 52 A010980P EPS 1 ...

Page 311: ...2 connects as a loop to the CO2 reference electrode Remove electrode by turning the electrode retainer nut Figure 9 53 6 Remove electrode retainer nut 1 Remove membrane as follows Separate the membrane retainer 3 assembly from the electrode Remove the quad ring 4 from the retainer Inspect the electrode port if the quad ring is not on the electrode Separate the membrane retainer from the membrane c...

Page 312: ... from the package in the Maintenance Kit Rinse the membrane thoroughly on both sides with deionized water Gently dry the membrane with lintless tissue Use the packaged membranes that are separated by pink spacers Figure 9 55 2 Place the membrane clamp 2 on a flat surface Using tweezers carefully center the membrane 1 on top of the membrane clamp Figure 9 56 ...

Page 313: ...ne clamp 3 Press the membrane retainer into the clamp thus securing the membrane 2 Figure 9 57 4 Place theretainerassembly upside down on thework surface so theclampis on top and retainer on the bottom Grasp the electrode carefully and press it firmly against the membrane and into the membrane clamp Figure 9 58 ...

Page 314: ...membrane is not centered correctly or is damaged repeat Steps 1 4 with a new membrane Figure 9 59 CAUTION Do not touch membrane surface when installing the quad ring 6 Reinstall the quad ring 1 onto the membrane retainer When installed the quad ring must be on the very end of the CO2 electrode This ensures a proper fluid seal when the electrode is installed in the flow cell Figure 9 60 ...

Page 315: ... for an extra or missing quad ring 4 Reconnect tubing lines 33 and 32 to the electrode Remove hemostats Make sure the tubings fit tightly on the electrode port 5 Reconnect the electrode cable to the appropriate connector 6 When the necessary electrode service is completed and the electrode is properly replaced select OK to exit the Maintenance pop up confirmation window NOTE While the system is pr...

Page 316: ... 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 you perform this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter 1 Loosen the two Phillips screws on the ISE module cover and remove the cover 2 Release the locking pin on the ISE module a...

Page 317: ...les meet For DxC 600 Systems trace the solenoid wiring to its source and disconnect Pull apart the valve connector to disconnect Figure 9 61 5 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 IMPORTANT DO NOT REMOVE the two screws on the drip tray Removal or repo...

Page 318: ... 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 9 63 7 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 9 64 ...

Page 319: ...lution through the valve port This flushes the sample inject area Allow the bleach solution to sit for one minute The one minutewaiting period applies only to the 10 bleach solution and not to the following deionized water or 70 isopropyl alcohol 10 Repeat the flushing procedure through the valve port using deionized water 11 Repeat the flushing procedure through the valve port using 70 isopropyl ...

Page 320: ...e one minutewaiting period applies only to the 10 bleach solution and not to the following deionized water or 70 isopropyl alcohol 15 Repeat the flushing procedure through the flow cell exit port using deionized water 16 Repeat the flushing procedure through the flow cell exit port using 70 isopropyl alcohol 17 Repeat the flushing procedure through the flow cell exit port using deionized water 18 ...

Page 321: ...es 18 24 23 26 and 15 to the EIC ports Refer to Figure 9 63 21 Remove clamps from lines 18 24 23 and 26 22 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 23 Reconnect the solenoid valves at the valve connector 24 Select OK to close the Mai...

Page 322: ...zed water Use within 24 hours CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when you perform this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter 1 Loosen the two Phillips screws from the ISE module cover and remove the cover 2 Release the locking pin on the ISE module and lift the module until it...

Page 323: ...e Wait for prime cycles 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 as follows Select the ISE CO2 Alkaline Buffer check box Type 15 in the Number of primes to repeat field Select Sta...

Page 324: ...possibly causing recovery anomalies for NA and CL To prevent this build up from occurring the drain should be cleaned periodically CAUTION To prevent damage due to electrical static discharge ESD wear the wrist ground strap when you perform this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter 1 Loosen the two Phillips screws on the ISE module ...

Page 325: ...o not lose the attached metal drip screen 2 The top may require slight wiggling back and forth to remove Figure 9 68 5 Carefully set aside the drain top with tubing 22 attached 6 Remove the drain tube 1 from the drain Figure 9 69 7 Using four to five cotton swabs soaked with deionized water clean the inside of the lower drain and the top of drain ...

Page 326: ...drain IMPORTANT Do not pinch damage or disconnect the adjacent connector wires while reinstalling the drain top 10 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 the mount Tighten the screw at drain top 11 Select OK to exit the Main...

Page 327: ...ESD wear the wrist ground strap when you perform this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter 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 lift the module until it clicks into a raised locked position 3 Prepare for ISE Maintenance and disable autoprime Sel...

Page 328: ...he top of the flow cell Remove line 27 from the front of the flow cell in order to allow residual acid to leak out 7 Draw back on the syringe This withdraws any remaining solution left in the flow cell and removes any material that can be causing the occlusion of the small lumen NOTE The procedure may be concluded here if the problem has been resolved Proceed to Step 10 If the problem is not resol...

Page 329: ...e lines to the flow cell and remove the hemostat 11 When 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 12 Prime the flow cell 5 times Select Utils 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 CAUTION Pinch hazard Keep fingers clear...

Page 330: ...ation failures due to range or span errors Under extreme situations control and sample recoveries vary due to inaccurate calibrations As instructed by Hotline or Service Engineer IMPORTANT System does not autoprime in maintenance move After completion a maintenance procedure or if a procedure is aborted exit the Maintenance menu to resume autoprime and return the system to Standby A calibration of...

Page 331: ...s screws on the ISE module cover and remove the cover 2 Release the locking pin on the ISE module and lift the module until it clicks into a raised locked position 3 Prepare the flow cell for maintenance Select Utils from the menu bar 2 Maintenance 3 ISE Service Continue 4 Remove line 23 from the bottom of the flow cell see Figure 9 72 A Luer connector and small diameter tubing may be found in the...

Page 332: ...o the bottom of the flow cell 10 When the necessary cleaning is completed select OK to close the dialog box IMPORTANT Reagents immediately prime through the flow cell While the flow cell is priming verify there are no fluid leaks 11 After the pop up message appears select Close to exit the ISE Service screen 12 Rinse the syringe connector and tubing with deionized water Dry and store for future us...

Page 333: ...inside of the probe Materials Required Probe Cleaner Tubing Assembly PN 756613 Small cup for collecting wash solution 50 mL of 10 dilution of Wash Concentrate II solution per probe CAUTION To prevent damage due to electrical static discharge ESD wear a wrist ground strap when you perform this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter 1 P...

Page 334: ...pensed Empty the collection cup as often as necessary 7 Remove the cleaning assembly from the probe Clean the probe tubing fitting with a cotton swab wrapped in lintless tissue and moistened with deionized water Dry the probe tube fitting with a cotton swab wrapped in lintless tissue 8 Reconnect the DI water line into the black fitting at the top of the probe 9 Home the instrument Select Instr Cmd...

Page 335: ...scharge ESD wear a wrist ground strap when you perform this procedure For further instructions refer to Basic Laboratory Practice in the beginning of this chapter Replace the Old Probe 1 Press the STOP button on the instrument to stop all motors 2 Using a 3 8 inch open end or adjustable wrench loosen the nut 1 at top of probe Figure 9 74 3 Pull downward first on the probe then up and to the side t...

Page 336: ...h a wrench until it makes solid contact and locks within the fitting 5 Wipe the outside and bottom portion of the probe with 70 isopropyl alcohol Proceed to Additional Procedures in this section Additional Procedures Home prime and align the system to resume proper system operation 1 Select Instr Cmd 1 Home 2 Select Utils from the menu bar 1 Prime Prime the probe that was replaced one time and wat...

Page 337: ...ample Probe EIC Height If a new CC Sample Probe is installed CC Sample Probe Vertical Home and Wash CC Sample Probe Cuvette Height CC Sample Probe Sample Height If a new Reagent Probe is installed in either position Reagent Probe A or B Vertical Home and Wash Reagent Probe A or B Height in Cuvette Reagent Probe A or B Height in Cartridge If the bead assembly is removed or repositioned all rotary a...

Page 338: ...ontrols to confirm proper instrument performance If the controls are out but there are no visible leaks 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 wash port A007375L EPS 1 2 3 4 5 A007376L E...

Page 339: ...An empty chem position to load CC side Load F1 Scan Chemistry Wash Solution Cartridge CCWA 2 The Wash procedure is accessed select Utils 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 on the screen 3 To perform the procedure Select Continue OR Select Cancel to exit this screen without performing the p...

Page 340: ...It is suspected that a dirty collar wash assembly is causing increased level sense errors Materials Required One sample rack One 2 mL cup Undiluted household bleach Sodium hypochlorite 5 25 PN A32319 1 Select Utils from menu bar 4 Diagnostics Functional Area 1 Sample System Subfunctional Area 1 MC Chemistry Sample Crane Test Number 1 Level Sense Test 2 Type the Rack ID into the Rack ID field Selec...

Page 341: ...tils from the menu bar 1 Prime MC F4 Sample Delivery Subsystem check box Type 5 in the Number of primes to repeat field Start Prime The collar wash assembly is rinsed with water If necessary clean the exterior of the MC sample probe Refer to Weekly Maintenance Clean Probes Exterior in this chapter Clean the Precipitate in PHOSm DxC 800 Only The phosphorus PHOSm cup should be cleaned when protein p...

Page 342: ...ume autoprime Return the system to Standby Inspect the Cuvette Washer Probe The following procedure is used to inspect the cuvette washer probe If the cuvette wash station probe is obstructed by debris such as glass from a broken cuvette the DxC may provide inaccurate results If any of these steps fail contact Beckman Coulter Support Center or a local Beckman Coulter representative to identify and...

Page 343: ...system If the water pressure is adequate check the probe tips for broken glass 6 When the priming has stopped turn the wash station to check the tips of the probes for obstructions Check for debris like glass from the cuvettes or resin beads which can cause a blockage of the probes Manually remove any obstruction You can use a small can of compressed air to remove the blockage by blowing air throu...

Page 344: ...tion the probes 1 through 3 Near the bottom of three 2 0 mL sample cups one probe per cup OR Near the bottom of three small sample tubes one probe per tube NOTE Do not push the probes against the bottom of the sample containers This restricts the vacuum 12 Prime the wash lines one time Select CC F2 Cuvette wash 13 Type 1 in the Number of primes to repeat field 14 Select Start Prime Check the cups ...

Page 345: ...e Maintenance menu to resume autoprime and return the system to Standby 1 Select Utils from the menu bar 2 Maintenance 6 Wash All Cuvettes Follow all instructions on the screen 2 Select Continue to perform the procedure You can exit this procedure at any time before it is completed To exit select STOP on the instrument wait for system to finish processing OK to clear the pop up message Cancel to e...

Page 346: ...t the Maintenance menu to resume autoprime and return the system to Standby Materials Required CCWA cartridge PN 657133 1 Load the CCWA cartridge on the system Select Rgts Cal from the menu bar An empty chem position to load Load F1 2 Select Utils from the menu bar 2 Maintenance 9 CC Reagent Wash All Cuvettes OR Type 9 in the Procedure No field and press Enter Follow all instructions on the screen...

Page 347: ...usel cover 2 Figure 9 78 2 Scrub the covers with a good grade of disinfectant soap and a soft brush 3 Rinse the covers in deionized water Dry thoroughly using lintless tissue 4 Reinstall the covers 5 Wipe all exposed surfaces on the system with a 10 bleach solution one part 5 25 sodium hypochlorite PN A32319 combined with nine parts deionized water The surfaces include sample rack area covers pull...

Page 348: ...mination of racks may result in rack label damage If the label starts to bubble or peel remove and replace with a new label Decontaminate the Instrument This procedure provides instructions for cleaning and decontaminating system tubing waste sumps and reservoirs Perform this procedure when microbial contamination is either evident or suspected This procedure should take about 1 5 2 0 hours CAUTIO...

Page 349: ...om the menu bar Select 2 Maintenance Select 5 Hydropneumatic Maintenance Proceed to Step 2 only when the following message appears The Hydropneumatic system has been shut down 2 Open the lower middle compartment door release latch 1 on the hydropneumatics drawer and pull out the hydropneumatic system Figure 9 79 A016466P EPS 1 ...

Page 350: ...remove the DI Water reservoir and DI Water canister Figure 9 80 4 Empty the canisters Then fill the canisters and the empty Wash Concentrate bottle with a 10 bleach solution about two thirds full 5 Install both canisters with the 10 bleach solution back onto the system using the spanner wrench tool if necessary Make sure the large O ring is in place and both canisters fit tightly 6 Install the Was...

Page 351: ...Repeat Steps 1 8 three more times 10 After the last prime is completed allow the system to sit idle with 10 bleach solution for ten minutes 11 Remove both DI Water canisters and the Wash Concentrate bottle from the system Use the spanner wrench tool if necessary Empty out the bleach solution and rinse out the canisters with DI water 12 Install both canisters back onto the system using the spanner ...

Page 352: ... be observed when doing maintenance service or troubleshooting activities on the system This includes but may not be limited to wearing gloves and eye shields and washing hands after working on contaminated portions of the system Materials Required 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 ...

Page 353: ...cer Carriage moves up and causes a pinch hazard Remove the Cap Piercer Cover The Cap Piercer Cover must be removed to get access to the Cap Piercer Assembly Refer to Figure 9 81 and perform the following procedure 1 Lift the instrument cover 2 Use a flat edge screwdriver to fully loosen the two screws 1 from Cap Piercer Cover 2 Figure 9 81 3 Lift and remove the Cap Piercer Cover and set it aside A...

Page 354: ...re 9 82 Remove the Blade Assembly and Wick Clip Assembly as follows 1 Refer to Figure 9 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 avoid the bottom of the Wash Tower Figure 9 82 A007557P EPS 1 2 4 3 ...

Page 355: ...E 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 9 83 3 Put the Blade Assembly onto a plastic tray DO NOT touch the Blade A007558P EPS 1 ...

Page 356: ...t 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 materials Figure 9 84 A007559P EPS 2 1 1 3 ...

Page 357: ...red use the tray to carry blade wick items to other locations Clean the Blade as follows 1 Refer to Figure 9 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 9 85 A007560P EPS ...

Page 358: ...e 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 9 86 3 Put the Blade Assembly back on the same tray A007561P EPS ...

Page 359: ...re 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 apply 10 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 Gloss lubricant This lubricant is extreme...

Page 360: ...e injury or exposure avoid the Blade area 3 Lift up the Blade Assembly again as shown in Figure 9 83 Put the Blade Assembly back on the plastic tray 4 Remove the Wick Clip Assembly again as shown in Figure 9 84 Examine the bottom of Wick area for any loose fibers Remove any loose fibers with scissors NOTE Loose fibers clog the drain 5 Repeat Steps 1 and 2 above 6 Align Blade Holder 2 to screw hole...

Page 361: ...n 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 the bottom of each cap to confirm that the ca...

Page 362: ... portions of the system MOVING PARTS HAZARD Do not place hands near any moving parts while the system is operating 3 Refer to Figure 9 88 Lower the clear plastic cover 1 Disconnect both pump tube fittings 2 and 3 and move the tube out of both pinch clamps 4 and 5 Manually rotate the pump roller mechanism 6 approiximately half a turn while removing the tube Use caution as the tube may contain resid...

Page 363: ...s properly positioned under the pump rollers and is not twisted 7 Select Close to exit the maintenance procedure and return the system to Standby 8 Select Exit F10 9 Select 1 Prime 10 Select All Hydropneumatic Subsystem from the Prime dialog box Type 5 in the Number of primes to repeat field Start Prime 11 As the ISE primes check for leaks or bubbles from the tube or fittings ISE waste draining an...

Page 364: ...A13914AF 9 128 Maintenance As Needed As Required Maintenance ...

Page 365: ...seconds Cycle count information and cuvette cleanliness data are also provided IMPORTANT The Status icon on the menu bar is highlighted whenever a warning or error condition 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 Show Status Summary 1 Select Status from the men...

Page 366: ...may be periodically collected by Beckman Coulter using the instrument modem Show Cycle Count 1 Select Status from the menu bar 2 Select the Count tab A summary of the monitored areas appears Table 10 1 Status Messages Status Description Error Parameters which exceed allowable limits are called errors If any of the parameters in a monitored area exceed the allowable limit Error appears with a red h...

Page 367: ... instrument components for example reaction carousel cups cuvette wash 1 Select Status from the menu bar Table 10 2 Counters Counter Description Modular 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 r...

Page 368: ...pplies OK Warning or Error with the same highlight colors Show the Power Subsystem Status 1 Select Status from the menu bar 2 Select the Power tab A summary of the monitored areas appears Hydropneumatics Subsystem Introduction Status for the Hydropneumatics Subsystem shows the status for all of the reservoirs canisters and sumps A yellow highlight indicates a warning condition and a red highlight ...

Page 369: ... of the air and vacuum pressures refer to the UniCel DxC Synchron Clinical Systems Reference Manual If the Waste B exit sump shows Paused it has been stopped either automatically by the system when the WasteB containeris full or by operatorrequest Foradditional information refer to Pause Resume Waste B in this chapter ICS Smart Modules Introduction ICS Smart Module status monitors the power to the...

Page 370: ...eset or powered off When absorbance values are lost the absorbance value will be zero until a water blank test is run Show the Cuvette Water Blank Status 1 Select Status from the menu bar From the Summary tab under Cuvettes out of limit either None or 1 or more dirty appears 2 Select the CuvStat tab 3 Use the scroll bar to view the various cuvettes If any of the absorbances are out of limit the cu...

Page 371: ... 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 shows its Serial number Last update d...

Page 372: ... 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 system is running Resume Waste B resumes the dumping of Waste B to the external container Enable Disable Modules enables or disables modules Unload all racks unloads all racks Home Introduction Home is used to mo...

Page 373: ...ts from being started without wasting sample or reagent as pressing STOP does Those tests that already had reagent pipetted will run to completion but no new tests will be scheduled This feature can pause the MC side the CC side or both the MC and CC sides of the instrument The system will transition the paused side s of the instrument from Running to Pausing and eventually will reach Standby To r...

Page 374: ...the Pause dialog box select 1 MC Only 2 CC Only OR 3 Both MC and CC OR Table 10 3 Alternatives Instead of Pause for Some Situations Situation Instead of Pause Imminent danger to a person or the instrument Press the STOP button or turn off power Reagent needs to be loaded while the system is running Perform a reagent load as usual and the system automatically interrupts reagent additions to allow t...

Page 375: ...nt requests that are still in the print queue and prevent them from being sent to the printer This feature is useful in stopping print requests composed of many pages such as the entire Event Log some QC reports or preventing multiple print requests 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 t...

Page 376: ...on Clinical Systems Reference Manual Shutdown 1 Verify that the system is in Standby or Stopped 2 Select Instr Cmd from the menu bar 3 Select 4 Shutdown 4 Select OK The Shutdown in Progress screen appears with the message Please wait for further instructions DO NOT TURN THE POWER OFF The system status goes to Shutdown 5 From the Select Reboot or Shutdown dialog box select the appropriate option Re...

Page 377: ...ect of line voltage changes that could damage the sensitive electronic components 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...

Page 378: ...a functional state by performing system initialization running boot diagnostics and loading the operating system Power Up Sequence The following procedure describes the power up sequence often referred to as a hard or cold boot Use this procedure after an instrument shutdown 1 If the monitor is off turn it on 2 If the printer is off turn it on 3 Press the power button to turn on the console If you...

Page 379: ...ture errors should be ignored The Glucose sensor may drift over the first 24 to 48 hours Verify control recovery at 4 hours and recalibrate if necessary More frequent calibration may be required during the first 24 to 48 hours following installation Reset For instructions on how to perform a reset or reboot refer to Shutdown in this chapter Pause Resume Waste B Introduction TheWaste B option allow...

Page 380: ...ion Enable Disable allows the user to Enable and Disable an individual subsystem module the MC side or the CC side This function allows some subsystems to operate while others are disabled due to error conditions Additional Information The user can manually enable or disable the following items One or more individual MC modules cups and ISE All of the MC side Photometer LPIA Module All of the CC s...

Page 381: ... running the system IMPORTANT When a module is Enabled the system will go to Standby as it prepares for a prime The system will not accept work requests at this time Reagents should be reloaded when a module is Enabled to ensure that fresh reagents are used for subsequent testing Disable Modules 1 Select Instr Cmd from the menu bar 2 Select 7 Enable Disable Modules 3 Select the desired module butt...

Page 382: ... second delay before the system starts to prime NOTE Do not press RUN during this eight second delay Samples would not be run NOT ACCEPTED error because the system is priming Unload All Introduction Unload All is used when the instrument is in Standby It removes all the sample racks from the sample carousel to the offload track It can be used When access to a sample is required or After a system e...

Page 383: ...l Racks 1 Select Instr Cmd from the menu bar 2 Select 8 Unload All Racks OR Type 8 in the Command Number field and press Enter 3 All racks on the sample carousel are removed and the Instrument Command window closes An empty sample carousel is shown on the Main screen ...

Page 384: ...A13914AF 10 20 System Status and Commands Unload All ...

Page 385: ...component refer to the tables below This feature is only available when the system status is in Standby Table 11 1 A Prime for the CC Subsystems CC Subsystems Function Reagent Delivery Subsystem Washes the reagent probes and mixer primes the reagent syringe Sample Delivery Subsystem Washes the CC sample probe and mixer primes the sample syringe Cuvette Wash Station Primes cuvette wash Probes 1 and...

Page 386: ...TPm DxC 800 only Primes Total Protein Reagent and or water BUNm UREAm DxC 800 only Primes BUN UREA Reagent and or water Table 11 4 A Prime for Other Components of the MC Subsystems MC Subsystems Function ISE Module all Primes all reagents used by the ISE module Electrolyte Buffer Primes Electrolyte Buffer Reagent Electrolyte Reference Primes Electrolyte Reference Reagent EIC Wash Primes DI water t...

Page 387: ... having to select each individual subsystem Follow the steps below to prime a group of subsystems 1 Select Utils from the menu bar 2 Select 1 Prime OR Type 1 in the Option Number field and press Enter 3 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 4 ...

Page 388: ... if any two are selected 1 Select Utils from the menu bar 1 Prime OR Type 1 in the Option Number field CC F2 2 Select one or a combination of the following check boxes Reagent Delivery Subsystem Sample Delivery Subsystem Cuvette Wash 3 Type the desired number of primes 1 99 in the Number of primes to repeat field 4 Select Start Prime The system status changes to Priming and the number of primes re...

Page 389: ...ystems MC Subsystem Prime allows the priming of the cup modules the ISE flow cell and EIC and the Sample Delivery Subsystem If a cup selection is made and neither reagent or DI water is specified only DI water will be primed into the cup If both reagent and DI water are selected both will be primed and the cup s will be left full of DI water Whenever Acid is primed Reference must also be primed to...

Page 390: ...intenance 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 9 Maintenance in this manual for maintenance instructions Event Log Introduction The Event Log is a record of events and errors that are logged for example CAU DI Water Canister Level Low Mes...

Page 391: ... Errors 180 000 7 Other Console Errors 10 000 8 Input Device Events 15 000 9 Other Console Events 10 000 10 Sample Processing Events 60 000 11 Deleted Results 10 000 Table 11 7 Information in the Event Log Event information Definition Number Sequential number identifying the order with number one representing the most recent entry Class Number corresponding to the 1 10 event classes listed on the ...

Page 392: ...4 To print the information select Print This will print the entire selection not just the page currently shown Table 11 8 Event Classes Information Options Option Description Display Display Events for reviewing events on the screen Copy Copy to diskette for saving events to a disk as a permanent record for viewing on another system or sending to Beckman Coulter Time Date and Time selection for se...

Page 393: ...for further investigation 1 From the Events Log dialog box select the event log classes and a date time range if desired 2 Select Copy from the Event Log dialog box OR Select Copy to Disk from the Display Events dialog box 3 Insert an MS DOS formatted diskette into the disk drive 4 Select OK to transfer information to a diskette OR Select Cancel to exit without copying the information 5 While the ...

Page 394: ...ieved if a To date is specified a From date is required if hours are entered but no minutes 00 minutes is used After selecting the desired Event Classes follow the steps below to specify the desired date and time period 1 Select Time from the Event Log dialog box 2 Type desired time period Press Tab to advance the cursor to each field 3 Select OK to accept the time period OR Select Cancel to exit ...

Page 395: ...printer If no selections are made the entire Event Log will be printed Print is available from both the Event Log dialog box without having to view the data first or can be selected from the Display Events dialog box Print always sends the complete selection to the printer If a print of the current page screen is required press PrtScn from the keyboard IMPORTANT Use the Print function carefully wh...

Page 396: ...nstructions Metering Reagent Metering Reagent Metering provides reagent dispense counting and replenishment adjustments for those instruments that are on a cost per test contract Metering is only initialized on those instruments with a cost per test contract Metered Use Instruction Manual Refer to the Synchron Clinical Systems Metered Use Manual for instructions on usage Modem The modem attached t...

Page 397: ...ng photometer data Backup the System The backup procedure should be performed following installation 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 mor...

Page 398: ...ore copying data 6 Select OK The diskette is then formatted and the backup files are created 7 When the backup is complete a confirmation message appears Select OK 8 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 Parameters and A...

Page 399: ...les box 3 Select Restore OR Select Cancel to exit without restoring 4 Insert the backup diskette into the 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 The system prompts you ...

Page 400: ...ration install the monitor in a stable postition at eye level if possible Alignment Data Alignment Data includes all alignment information including photometer data Procedure Calibrate the touch screen in the same position sitting or standing as most operators work Follow the steps below to calibrate the touch screen 1 Select the Utils icon from the menu bar 2 Select 10 Touch Screen Calibration 3 ...

Page 401: ...22 Fluid level low 9 21 Check fluid level 9 23 Replace alkaline buffer reagent 9 18 Archive QC Data 5 23 Auto ORDAC 3 4 Auto serum index 3 4 Autoloader 1 9 B Backup 11 13 Alignment data 11 13 11 16 System parameters 10 2 11 13 Bar code reader 1 19 Hand held MC 1 13 Reagent CC 1 19 Sample 1 10 Bar codes QC 5 7 Printing 5 7 Beer s Law 1 54 Boot Full boot 10 14 Buttons 1 xxxiv C Calibration Acceptanc...

Page 402: ...9 76 Wrinkled 9 78 Configuration system 3 31 Constituent code 5 6 5 11 Control 5 9 5 14 Bar codes 5 7 Constituent code 5 6 5 11 Definition 5 4 Deleting 5 13 Editing 5 9 Fields 5 6 5 11 File number 5 6 5 11 Printing 5 13 QC chart 5 17 QC file list 5 14 QC summary 5 15 Reviewing 5 12 Copy to disk feature 5 21 Creatinine clearance results Calculation 3 23 Critical ranges 3 19 Critical Result Rerun 3 ...

Page 403: ...ons Manual P N A16150 Hydropneumatic system 1 24 Status 10 5 I Icons 1 xxxiv ICS smart module status 10 5 Immediate reporting 3 14 Instrument commands 10 8 Intended use 1 xxxiii ISE Ion selective electrode flow cell module 9 2 ISE drain cleaning six month Drain top 9 89 Drip screen 9 89 ISE service 9 88 9 91 ISE module 1 13 ISE reference solution 9 52 ISE service 9 54 9 64 K Keyboard 3 29 L Labels...

Page 404: ...rs 8 8 Programming samples 6 1 Batch 6 11 Dilution factor 6 10 Manual 6 10 Manual assignments 6 7 ORDAC 6 10 Rack status 6 3 Rack cup position 6 4 Sample ID 6 4 Sample status 6 4 Pushers 1 10 Q QAP Disk 5 21 Quad ring BUNm UREAm electrode 9 27 CO2 measuring electrode 9 75 Potassium and calcium electrode 9 56 9 66 Quality Assurance Program QAP Copy to disk feature 5 21 Quality control QC 5 1 5 25 C...

Page 405: ...ervice Monitor 3 27 See also Metering Manual P N 967259 Setup 3 30 Setup Screens 3 1 Shutdown 10 12 Shuttle 1 10 Silicone compound 9 28 Smart modules Status 10 5 Sodium Azide preservative 2 vii Software version 3 23 Special calculations 3 20 Specifications system Clearances 1 2 Elevation 1 3 Operating temperature 1 3 STAT 3 14 Statistical summary report 7 10 Status Alarm Annunciator 3 32 See also ...

Page 406: ...uirements 8 1 Removing 8 19 Setup 3 24 8 3 V Valid entries 6 5 Version information 3 23 Version upgrade 3 31 W Warnings reagent and calibration status 4 15 Wash Concentrate II 9 10 Waste B pause resume 10 15 Wavelength Primary 8 6 8 15 Secondary 8 6 8 15 Westgard rules 5 2 5 3 Wheel See Carousel Wrist ground strap 9 43 ...

Page 407: ......

Page 408: ...nt to run most 20 test general chemistry panels UniCel DxC 600 and DxC 800 Synchron Clinical Systems In Lab Training Manual Used to train laboratory personnel on DxC 600 and 800 routine operations UniCel DxC 600 and DxC 800 Synchron Clinical Systems Operator Tips Provides a summary of frequently used information about your system and the chemistries used UniCel DxC Synchron Clinical Systems Host I...

Page 409: ...Instructions For Use Volume 2 UniCel DxC Synchron Clinical Systems For In Vitro Diagnostic Use This manual is intended for UniCel DxC 600 UniCel DxC 800 UniCel DxC 600i Beckman Coulter Inc 250 S Kraemer Blvd Brea CA 92821 ...

Page 410: ...the property of their respective owners Find us on the World Wide Web at www beckmancoulter com Beckman Coulter Ireland Inc Mervue Business Park Mervue Galway Ireland 353 91 774068 Beckman Coulter do Brasil Com e Imp de Prod de Lab Ltda Estr dos Romeiros 220 Galpao G3 Km 38 5 06501 001 Sao Paulo SP Brasil CNPJ 42 160 812 0001 44 製造販売元ベックマンコールター株式会社東京都江東区有明三丁目 5 番 7 号 TOC 有明ウエストタワー贝克曼库尔特有...

Page 411: ...eagent Handling System 1 17 Cuvette Reaction System 1 21 Hydropneumatic System 1 24 Operation and Control Components 1 26 Main Screen and Program Structure 1 27 Theory of Operation 1 43 Cartridge Chemistry Calibration Theory 1 43 Modular Chemistry Calibration Theory 1 53 Cartridge Chemistry Principles of Measurement 1 54 CHAPTER 2 Preparing Samples for Analysis 2 1 Routine Operation Overview 2 1 P...

Page 412: ...ical Ranges Setup 3 19 Sample Comments Setup 3 19 Special Calculations Definition 3 20 Timed Urine and Creatinine Clearance Results 3 23 Version Information 3 23 Units Precision Setup 3 24 User Defined Chemistries Setup 3 24 Bar Code Setup 3 25 Maximum Sample Program Age 3 26 Reserved Racks Obstruct Detect 3 26 Disable Service Monitor 3 27 Host Communications 3 28 Language Keyboard Setup 3 29 Prin...

Page 413: ...hemistry Bypass 4 25 Extend Calibration Time 4 26 Calibration Acceptance Limits 4 27 Calibrator Set Point Modifications 4 28 Slope Offset Adjustment 4 29 Reprint Calibration Reports 4 31 CHAPTER 5 Quality Control 5 1 Quality Control 5 1 Define a Control 5 4 Control ID Assignments 5 7 Run Control Samples 5 7 Edit a Control Definition 5 9 Review a Control Definition 5 12 Delete a Control 5 12 Print ...

Page 414: ...ID 7 4 Recall Results by Run Date Time 7 4 Display Recalled Results 7 5 Edit Critical Rerun Result 7 6 Print Recalled Results 7 7 Send Results to the Host 7 8 Absorbance Versus Time 7 8 Statistical Summary Report 7 10 CHAPTER 8 User Defined Reagents 8 1 Overview 8 1 Requirements and Precautions 8 1 User Defined Reagent Setup 8 3 Chemistry Parameters 8 4 Processing Parameters 8 8 Error Detection Li...

Page 415: ...nance 9 54 As Needed As Required Maintenance 9 66 CHAPTER 10 System Status and Commands 10 1 Overview 10 1 System Status 10 1 Status Cycle Count 10 2 Temperatures 10 3 Show Temperature Status 10 3 Power Subsystems 10 4 Hydropneumatics Subsystem 10 4 ICS Smart Modules 10 5 Cuvette Water Blank Status 10 6 CTS Tracking 10 7 Instrument Commands 10 8 Home 10 8 Pause 10 9 Stop Print 10 11 Shutdown 10 12...

Page 416: ...Calibration 11 16 CHAPTER 12 Troubleshooting Calibration and Result Errors 12 1 Calibration Errors 12 1 MC Calibration 12 2 Linear Calibration 12 7 Non Linear and Multipoint Calibrations 12 10 Troubleshooting Result Errors 12 13 Error Codes and Definitions 12 14 Error Code Definitions 12 17 Common Error Messages and Corrective Actions 12 1 Glossary Glossary 1 Index Index 1 Related Documents ...

Page 417: ...sult 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 12 1 below is a general list of the calibration errors for linear multipoint and MC calibrations These errors are listed in...

Page 418: ...easure of system precision during calibration 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...

Page 419: ...lect Calibrator Acceptance Limits under Options in the Rgts Cal screen to view current calibration limits DAC The DAC error check verifies proper operation of electrodes The Digital to Analog Conversion DAC check mimics expected ranges of electrode output Failure to detect an output within a predetermined range for each channel will trigger a DAC ERROR flag for the specific electrolyte Limits are ...

Page 420: ...f Calibrator 3 must exceed the minimum span limit Select Calibrator Acceptance Limits under Options in the Rgts Cal screen to view current calibration limits Calibration Reports The Calibration Report can be a useful tool for identifying issues Table 12 4 below defines the Fields in the order they are shown for each chemistry on a typical ISE Module Calibration Report Table 12 3 Maximum Allowable ...

Page 421: ...o an expected value and if the calculated span is less than the expected span the calibration is flagged Set Point The concentration value assigned to the calibrator level Set Point Units The units assigned to the set point value Replicates Used The field indicating which replicate of a calibrator level is used for a particular chemistry Failed Calibration Log ERR The fields listed below categoriz...

Page 422: ... Replicates Used The field indicating which two of the four calibrator replicates are used for a particular chemistry Span The difference between the average of the values reported for rate for each calibrator level This value is compared to an expected value if the calculated span is less than the expected span the calibration is flagged Failed Calibration Log ERR The fields listed below categori...

Page 423: ...cription 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 limits for all calibrated chemistries...

Page 424: ...fic 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 calibrator Blank The blank absorbance when it is an ENDPOINT chemistry or the blank rate absorbance per unit time when it is a RATE chemistry Reaction The reaction absorbance when it is an END...

Page 425: ...isk appears next to the value which is out of specification The corresponding error flag will print in this field Only those errors that FAIL the calibration will print Value Shows the absorbance value that failed calibrator or reaction limits Magnitude This is an indication of the severity of the failure Depending on the error the magnitude may reflect the actual value of the error or it may show...

Page 426: ... 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 of errors are inherent to non linear curve fitting and may or may not cause calibration failure Under certain conditions the curve fitting will produce paramete...

Page 427: ...und on those two reports Table 12 7 Non Linear Single Point and Multipoint Calibration Reports Field Definitions Field Description Reagent Identifiers The following fields identify specific cartridge information Rgt Indicates which chemistry is being calibrated Units Shows selected units for reference S N Specifies the serial number of the reagent cartridge being calibrated Lot Identifies the lot ...

Page 428: ...on report This is only shown if a calibration fails Reagent 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 occurred an asterisk appears next to t...

Page 429: ...eaction step performing outside of any one or more limits will be flagged message or remark A flagged sample value will not be reported Error Types and Description Result Errors and Codes describe the errors or system conditions which affect chemistry results The conditions are described in Table 12 8 below Calibration Error Log Error Flag Magnitude BLANK RATE absolute delta BLANK ABS absolute del...

Page 430: ...s are not printed on the report Instrument Code Instrument Codes are coupled with a chemistry code and indicate a condition tied to a specific chemistry These codes are printed on the report in the Instrument Code section Example 01AC translates to Sodium 01A Calibration Overridden C Some of these conditions will prevent the printing of a result IMPORTANT These codes are not located or transmitted...

Page 431: ...eds calibration CHEM NOT RUN Chemistry not run DAC ERROR ISE DAC Failure DIL1 LEV SENSE Level sense error in diluent cartridge DIVISION ERROR ZD Division Error Special calculation divisor is zero HI REAGENT MC reagent level high INCOMPLETE AB Calculation incomplete INSUFF DIL1 Insufficient diluent reagent for scheduled tests INSUFF REAG Insufficient reagent strength INVALID CHEM Invalid chemistry ...

Page 432: ...l ADC error high Results Suppressed INIT ADC LO LI Initial ADC error low Results Suppressed INIT COND HI CH Initial conductance high Results Suppressed INIT COND LO CL Initial conductance low Results Suppressed K REQ IK Bad K value Results Suppressed NA K REQ IN Bad NA value Results Suppressed OIR HI DH Out of instrument range high Results Suppressed OIR LO DL Out of instrument range low Results S...

Page 433: ...cannot be calculated and this error is reported Check your K and NA values for any error conditions K is required to calculate a urine NA result If K value has an error urine NA cannot be calculated Blank Absorbance High Low The mean absorbance measured during the reagent blank spin cycle read window exceeds expected limits The units are measured in absorbance and will characterize reagent quality...

Page 434: ...within each cup dependent on each type of reaction TPm and PHOSm noise is evaluated by determining the standard estimate of the error divided by rate for the rate ADC readings ALBm noise is determined by evaluating the maximum deviation between the four ADC readings for both reference and sample plus reference readings GLUCm and BUNm UREAm noise is evaluated using multiple rate readings used to de...

Page 435: ...s flag may also be triggered when experiencing temperature differences either external or internal to the system Initial Conductance Error High Low The initial conductance readings for GLUCm or BUNm are below or above acceptable limits This may be caused by poor reagent preparation poor electrode integrity or cup heater issues Initial Rate High Low For CC chemistries the reaction absorbance data o...

Page 436: ...esent on the system and the requested tests cannot be performed Not Ready The system is preparing to run the requested tests and the tests are Pending ORDAC Result Result was calculated using ORDAC feature Out of Instrument Range High Low The recovered value exceeds the value that the instrument will report Out of ORDAC Range High Low A reaction exceeded the range of ORDAC Over Range Detection and...

Page 437: ...the value Reagent Expired On board reagent has exceeded its Lot Expiration Date The result should be verified as acceptable before reporting the value Reagent Not on Board Tests could not be run as programmed reagent was not loaded on the system Reference Signal Noise The difference between the high and low values of the eight reference readings taken milliseconds apart has exceeded the limits all...

Page 438: ...nitial absorbance taken after sample or trigger reagent inject and the final absorbance data within the reaction read window exceeds specifications Rerun sample with ORDAC enabled if appropriate or dilute sample and rerun Temperature The operating temperature of the system is beyond 0 1 C from the set point value All cartridge chemistries will be reported with a flag Test Aborted Scheduled test ha...

Page 439: ... icon next to the event number to display specific information about the error A grey Help icon indicates that the Instructions For Use manual is not loaded For error messages that do not have a Help icon next to the event number refer to the UniCel DxC Synchron Clinical Systems Reference Manual for troubleshooting information Online Manual Links The system may display an Error The page cannot be ...

Page 440: ... Consistent messages may indicate issues with the Thermister Thermister cable Power Control Board Peltier Assembly Contact Beckman Coulter Support Center for additional information 0x01F90084 4 Power Smart Module Communication Error CAU SMC Receive Error Message ID 0x01F90084 Subsystem PWRMGR Msg Size number of bytes A communication error has occurred between the Power Distribution Board Smart Mod...

Page 441: ...is full flooded This is a safety mechanism that prevents a flood from getting into the pumps The Vacuum accumulator should never have any fluid in it and should be emptied whenever fluid is found during Maintenance Check the vacuum accumulator canister for liquid Empty if necessary Press the STOP button and Home the system If the error continues contact Beckman Coulter Support Center for additiona...

Page 442: ...servoir Is Not Filling At All CAU Wash Concentrate Reservoir Is Not Filling At All Message ID 0x01FA000B Wash Concentrate Reservoir Is Not Filling At All Load a new bottle of Wash Concentrate Refer to Load Unload Modular Chemistries MC 0x01FA0014 4 Both The Waste B Exit Sump And The Collection Bottle Are Full Switch 29 15 9 CAU Both The Waste B Sump And The Collection Bottle Are Full Message ID 0x...

Page 443: ... the Hydro is empty Contact Beckman Coulter Support Center for additional information 0x01FA0019 4 10 psi Air Supply Pressure Is Low CAU 10 psi Air Pressure Is Low Message ID 0x01FA0019 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 as foll...

Page 444: ...djust pressure levels if necessary as follows Make sure the 25 psi Main Pressure gauge on the hydro reads within 24 to28 psi Adjust the 25 psi Main Pressure regulator as necessary When the 25 psi pressure is within range make sure the High Pressure reading on the Hydro Status screen is 17 1 Adjust the low pressure system The pressure range for the low pressure system is 8 11 psi Set it at 10 psi C...

Page 445: ...reading on the Hydro Status screen is within range Adjust the 10 psi Low Pressure regulator as necessary If the instrument will not return to Standby contact Beckman Coulter Support Center for additional information 0x01FA001C 4 17 psi air supply pressure is high CAU 17 psi air pressure is high Message ID 0x01FA001C This error will occur whenever there is a problem within the high pressure system ...

Page 446: ...rea Likely cause is the Instrument computer has attempted to access a restricted area or file At the Red Message screen select Shutdown If the problem continues contact Beckman Coulter Support Center for additional information 0x025C0009 4 Instrument Computer Error CAU Bus Error Message ID 0x025C0009 Subsystem CAU Task Name task name Vector ID vector id Likely cause is the Instrument computer has ...

Page 447: ...d reagent cartridge Refer to Load Unload Cartridge Chemistries CC 0x02620017 2 CC Reaction Wheel Subsystem Motion Error CAU CC Reaction Wheel Subsystem Motion Error Message ID 0x02620017 Subsystem RASched Action Name action name This error will occur with any type of motion error within the Reaction Wheel Raise canopy and check for obvious obstruction of the Reaction Wheel Make sure sample and Rea...

Page 448: ... mixer or reagent syringe drive Make sure the reagent drip tray is installed properly Make sure the reaction carousel evaporation cover is installed properly Check the reagent syringe to make sure the plunger is seated correctly Press the DxC STOP button Wait for the motors to release power about 30 seconds listen for the sound of the Smart Modules resetting then Home the system While the system H...

Page 449: ...determine if the syringe or probe is responsible for the error If the CC sample probe is responsible perform the appropriate vertical or horizontal alignment Refer to Step 3 in the Install the New Probe procedure If the Syringe is responsible check for proper seating of syringe assembly Contact Beckman Coulter Support Center for additional information 0x0262001A 4 CC Sample Probe Obstruction Sampl...

Page 450: ...ion 0x0262001D 2 CC Reagent Probe A Motion Error CAU CC Reagent Probe A Motion Error Message ID 0x0262001D Subsystem RASched Action Name action name This error is caused by a Vertical or Rotary motion error This will cause the instrument to go into a Stopped state Raise canopy and check for obvious obstruction of the CC reagent Probe A Press the STOP button and Home the system While system is homi...

Page 451: ...r Support Center for additional information 0x02620020 2 CC Reagent Syringe Motion Error CAU CC Reagent Syringe Motion Error Message ID 0x02620020 Subsystem RASched Action Name action name This error occurs when there is an error within the CC Reagent Syringe Subsystem This includes both the Shear valve Motor and the Lead Screw Motor Raise canopy and check for proper seating of syringe assembly Pr...

Page 452: ... instrument back up Refer to System Power On Boot If the problem continues contact Beckman Coulter Support Center for additional information 0x02620024 2 CC Sample Mixer Motion Error CAU CC Sample Mixer Motion Error Message ID 0x02620024 Subsystem RASched Action This error occurs when there is a motion error within the Sample mixer crane These errors will occur while in Standby Priming or during r...

Page 453: ...velengths between 340 to 700 nanometers A cuvette s wavelength absorbance is over 200 mA Absorbance for the 940 nanometer wavelength PRO System only PSM Error LPIA Failure Remove wash station head and inspect probes for blockage and wiper for wear Refer to Replace Cuvette Wiper for removal of Wash Station Check wash station wiper alignment Check wash station alignment Remove reaction carousel and ...

Page 454: ...robe bead assembly reagent probe alignments level sense board Contact Beckman Coulter Support Center for additional information 0x0262003A 4 CC Sample Probe disabled due to obstruction errors CAU CC Sample Probe Disabled Due To Obstruction Errors Message ID 0x0262003A Subsystem ccScheduler Multiple samples had Obstructions Clots Try flushing probe from the top Refer to Flush the Sample and Reagent...

Page 455: ...ample rack handler and clear any obstruction found Home the system Reload any incomplete racks Press the RUN button to resume testing 0x02660001 4 No Diluent Cartridge CAU No Diluent Cartridge Message ID 0x02660001 Subsystem RASched Chem Name chem id Diluent cartridge must be loaded to performed requested tests Tests requiring the diluent cartridge will be incomplete Load a DIL1 Cartridge Refer to...

Page 456: ... Sample ID sample id Rack ID rack id Rack Position rack position Probe detected excessive vacuum in thick stopper closed tube on second attempt Sample is aborted Uncap tube and rerun If occurs consistently for many samples check cap piercer for broken blade Refer to Replace CTS Blade Wick 1 Blade Thick CTS Option or Replace CTS Blade 1 Blade Narrow CTS Option to inspect the blade Perform CC ODC Al...

Page 457: ...artup or homing the CC side is stopped Press the DxC STOP button Wait for the motors to release power about 30 seconds listen for the sound of the Smart Modules resetting then Home the system If the error continues contact Beckman Coulter Support Center for additional information 0x032B0005 2 CC Obstruction Detection Transducer Failure CAU CC Obstruction Detection Transducer Failure Message ID 0x0...

Page 458: ... Status for Reaction Carousel Temperature Refer to Temperatures Check Cuvette Status for a cuvette flagged in red This may indicate broken or cracked cuvette Refer to Cuvette Water Blank Status If a cuvette appears to be damaged replace it extra cuvettes available in Spares kit and may be ordered Press the STOP button and Home the system 0x03EA0009 4 Instrument Detected Power Loss CAU Instrument D...

Page 459: ...t attempt CAU MC Sample Probe Obstruction Message ID 0x04B2001E Sample ID sample id Rack rack Position position This error occurs when the MC sample probe ODC Obstruction Detection Correction sensor indicates that the probe is obstructed during sample aspiration No operator action is necessary The system will attempt a second aspiration from this sample 0x04B2001F 4 Unrecovered MC Sample Probe Obs...

Page 460: ...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 for broken blade Refer to Replace CTS Blade Wick 1 Blade Thick CTS Option or Replace CTS Blade 1 Blade Narrow CTS Option to inspect the blade Perform MC ODC Alignment 0x04B3000F 4 ISE DAC Setting Failed Chem Name chem id CAU ISE DAC Sett...

Page 461: ...ional information 0x04B30013 4 MC Sample Probe disabled due to obstruction errors CAU MC Sample Probe disabled due to obstruction errors Message ID 0x04B30013 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 Refer to Priming MC Subsystems select Sample Delivery Subsystem Probe may need to be replaced Refer to R...

Page 462: ...Contact Beckman Coulter Support Center for additional information If this error occurred during a rack unload check the results for the samples in the misread rack 0x057A0009 4 Duplicate Rack ID rack CAU Duplicate Rack ID Message ID 0x057A0009 Subsystem SRShttl Rack ID rack This error occurs during a load when a rack ID is read by the bar code reader and an identical rack ID is already present on ...

Page 463: ... CAU Rack Height Not Defined Message ID 0x057A000E Subsystem SRShttl CTS is installed and the sample rack does not have a height defined Make sure the rack height is defined Refer to Figure 2 2 Reserved Racks Obstruction Detection Setup Dialog Box 0x057B0008 4 Offload Track Is Full CAU Offload Track Is Full Message ID 0x057B0008 Subsystem SRLdr This error will occur when the offload trays sensor h...

Page 464: ...eter in the event log entry will show one of the following AttachRgtMixer error occurred attaching to smart module 0xC1 RecoverRgtMixer EnergizeRgtMixerVer RaiseRgtMixer error occurred during a vertical movement toward the home sensor flag HomeRgtMixerVer error occurred during a vertical movement away from the home sensor flag EnergizeRgtMixerCrn MoveRgtMixerToSensor error occurred during a horizo...

Page 465: ...sure the wiring and cabling are secured properly Make sure mixer paddle is seated firmly in its housing If mixer appears out of position perform rotary or vertical alignment Home and restart the system If motion error continues contact Beckman Coulter Support Center for additional information 0x05DC01FF 4 Sample Autoloader Error CAU Homing Error s Message ID 0x05DC01FF This error encompasses all h...

Page 466: ...check Event Log for specific subsystem errors Contact Beckman Coulter Support Center for additional information 0x05DC0201 4 CC Reaction Carousel Subsystem Error CAU Homing Error for CC Reaction Carousel Subsystem Message ID 0x05DC0201 Subsystem boot homing command An error occurred while homing the cuvette wash station or reaction carousel Check the Event Log classes 2 and 4 for specific reaction...

Page 467: ...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 error message Check Event Log for sp...

Page 468: ...ter for additional information 0x05DC0227 4 No Response From Hydro Subsystem CAU Homing Timeout for Hydro Subsystem Message ID 0x05DC0227 Subsystem boot homing command This error occurs when the hydro fails to respond to commands or fails to attach This event can be generated by any Hydro command sent by start dat including AttachHydro StartAutomonitor HydroInitStatus or HydroWatchdogOn Check Even...

Page 469: ...ce The system may still be in a Running state Allow samples to complete before requesting maintenance 0x1399002D 7 Printing for the system is down Please reboot the system at your earliest convenience All requested print jobs will need to be requested again after you have rebooted PRTMGR Task task error filename linenumber Logs that the printing is down in the event log and displays the note to in...

Page 470: ...efer to Rgts Cal Screen Overview Begin to prepare to calibrate required chemistries Refer to Request a Calibration 0x139F0037 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 The within lot calibration factor for the specified ch...

Page 471: ...emistries MC 0x139F0068 7 CTS Tracking Information can NOT be shared between all instruments When you move a tube to a different instrument remove its cap You will be notified when full CTS tracking is restored STM TS CTS Tracking System disconnect detected Message ID 0x139F0068 This error will occur whenever 1 or more instruments is no longer communicating Cut Tube Tracking information with the o...

Page 472: ...ck rack ID p PositionSample ID p PositionSample ID p PositionSample ID p PositionSample ID Rack has been loaded with a sample which has not been programmed Make sure the complete sample bar code is readable through the window in the rack Check communication with LIS Manually program if necessary Refer to Processing Samples Manually 0x13A00022 10 The QC Database is xx full Archiving is suggested WL...

Page 473: ...A00056 10 No sample programming or pending test found for samples in rack rack ID Rack will be unloaded from rack location WLM Nosampleprogramming or pending tests found for sample on rack Rack ID rack ID File Name Line Number A rack was loaded with nothing to run The rack is off loaded and any previous results are printed Check the sample status It may have been completed and reloaded Verify the ...

Page 474: ...through Instrument Commands WLM Received request to disable module Module File Name Line Number Specified module has been disabled automatically This will normally have severity of IM Enable the module under Instrument Commands Enable Disable Modules If the problem continues it could be a valve or vacuum problem 0x13A00092 10 Sample Programs are too old on rack rack number Position Sample ID 1 sam...

Page 475: ...ms are exhibited With Albumin ALBm Blood Urea Nitrogen Urea BUNm UREAm Glucose GLUCm and Total Protein TPm results are suppressed with an Initial Rate Low High Error Flag When three consecutive results are suppressed the Cup Module is disabled With Creatinine CREm suppressed results are reported with a Reaction Noise Error Flag The CREm Cup Module is not disabled it continues to run and reports su...

Page 476: ...gent has not been loaded MAINT ERROR Reagent has not been loaded File filename Line lineno Maintenance procedure aborted because the reagent has not been loaded Load the reagent and retry the request Refer to Load Unload Reagent 0x13A20019 7 MAINT ERROR Requested rack not loaded MAINT ERROR Requested rack not loaded File filename Line lineno Maintenance procedure aborted because the requested rack...

Page 477: ...not HOME CAU restart may be required File filename Line line number System is not in proper state for Homing usually still Stopping Must be Standby Stopped Disabled PVT Diag Maint or Align Wait for the system to get to Standby Stopped Disabled PVT Diag Maint or Align Reboot if necessary Refer to Shutdown 0x13A70005 7 Instrument not in proper state or Unable to send Home message ICMD Cannot HOME in...

Page 478: ...nstrument power is on and reboot Refer to Shutdown Continued errors may indicate an incorrect hardware address 0x13A70010 7 Instrument not in proper state ICMD Cannot disable Lower Reagent Carousel in current instrument state File filename Line line number CC was not in Standby Stopped state when the Lower Reagent Carousel was disabled Wait until the instrument goes to a Standby or Stopped state b...

Page 479: ...disk doesn t match Database Version number Backup Restore Database Version number on disk doesn t match Database Version num File file Line line 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 Refer to Backup the System 0x13AD0013 7 Error copying to floppy Backup Restore Error copying to floppy Fil...

Page 480: ...Version on disk doesn t match MPC SW Version File file name Line line num The contents of the backup are from a different version of the Console Software and cannot be restored on this version Use another disk if available Refer to Backup the System 0x13AD0040 7 Bad Floppy replace floppy and try Backup again Backup Restore Bad floppy cannot read from floppy during backup File file name Line line n...

Page 481: ...hat 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 and the Synchron Clinical Systems Chemistry Reference Manual Results exceeding these limits are flagged OIR HI or OIR LO Out of Instrument Range Antibody Ab A protein made by the body to defend itself against a foreign substance antig...

Page 482: ...ple The Bar Code Reader is a Class II fixed beam laser scanner It is used to read the rack bar code the sample bar code if present and the background bar codes as the rack travels past The rack bar code and sample bar code if present are used to identify the sample and link it to the appropriate sample programming Batch A group of samples with identical sample programming information with the exce...

Page 483: ...ituent Code A quality assurance QC program code that can be defined for a control chemistry Control ID The equivalent of a Sample ID for a control A maximum of eight unique Control IDs can be defined for each Control Name Critical Range A user defined range consisting of low and high values that are used to flag patient results as critical low or critical high CTS Closed Tube Sampling CTS Auto Glo...

Page 484: ... own separate container Double Trigger Two different reagent components added to the cuvette after sample addition that initiate the desired action Downgoing The decrease in absorbance as a reaction progresses EIC Electrolyte Injection Cup Electronic Maintenance Maintenance items are grouped together by frequency of performance Only the maintenance items appropriate for the particular system and i...

Page 485: ...he 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 Imprecision The lack...

Page 486: ...age Down to access additional pages Multipoint Span The difference between consecutive calibrator rates or absorbances The maximum of six consecutive calibrator rates seen on a standard curve for levels 0 1 1 2 2 3 3 4 4 5 5 0 Span indicates a measure of sensitivity over the entire curve No Foam Reagent additive automatically added to the system waste to prevent excessive foaming that may occur wi...

Page 487: ...eld Range Length Bar Code The limits of the code length which may be defined for a symbology Rate The type of reaction in progress while absorbance measurements are taken The reaction is expressed as rate of change Δ A min Reagent Acronym The two to five character abbreviation of the chemistry name Reagent Carousel The Reagent Carousel Compartment provides an on instrument storage area for the ind...

Page 488: ...esigned to perform a specific motion control or environmental function Special Character Any viewable or printable keyboard character that is not an alphanumeric character including the following _ Standby An instrument mode where all requested activity is complete and motion is stopped Start Stop Bits Synchronization method that signals the start and end of data transmission in serial communicati...

Page 489: ...xample mg dL mass volume for example mol L and International Units volume for example IU mL Upgoing Reaction The increase in absorbance as a reaction progresses 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 a...

Page 490: ...A13914AF Glossary 10 Glossary ...

Page 491: ...22 Fluid level low 9 21 Check fluid level 9 23 Replace alkaline buffer reagent 9 18 Archive QC Data 5 23 Auto ORDAC 3 4 Auto serum index 3 4 Autoloader 1 9 B Backup 11 13 Alignment data 11 13 11 16 System parameters 10 2 11 13 Bar code reader 1 19 Hand held MC 1 13 Reagent CC 1 19 Sample 1 10 Bar codes QC 5 7 Printing 5 7 Beer s Law 1 54 Boot Full boot 10 14 Buttons 1 xxxiv C Calibration Acceptanc...

Page 492: ...9 77 Wrinkled 9 79 Configuration system 3 31 Constituent code 5 6 5 11 Control 5 9 5 14 Bar codes 5 7 Constituent code 5 6 5 11 Definition 5 4 Deleting 5 13 Editing 5 9 Fields 5 6 5 11 File number 5 6 5 11 Printing 5 13 QC chart 5 17 QC file list 5 14 QC summary 5 15 Reviewing 5 12 Copy to disk feature 5 21 Creatinine clearance results Calculation 3 23 Critical ranges 3 19 Critical Result Rerun 3 ...

Page 493: ...ons Manual P N A16150 Hydropneumatic system 1 24 Status 10 5 I Icons 1 xxxiv ICS smart module status 10 5 Immediate reporting 3 14 Instrument commands 10 8 Intended use 1 xxxiii ISE Ion selective electrode flow cell module 9 2 ISE drain cleaning six month Drain top 9 90 Drip screen 9 90 ISE service 9 89 9 92 ISE module 1 13 ISE reference solution 9 52 ISE service 9 54 9 65 K Keyboard 3 29 L Labels...

Page 494: ...rs 8 8 Programming samples 6 1 Batch 6 11 Dilution factor 6 10 Manual 6 10 Manual assignments 6 7 ORDAC 6 10 Rack status 6 3 Rack cup position 6 4 Sample ID 6 4 Sample status 6 4 Pushers 1 10 Q QAP Disk 5 21 Quad ring BUNm UREAm electrode 9 27 CO2 measuring electrode 9 76 Potassium and calcium electrode 9 57 9 67 Quality Assurance Program QAP Copy to disk feature 5 21 Quality control QC 5 1 5 25 C...

Page 495: ...ervice Monitor 3 27 See also Metering Manual P N 967259 Setup 3 30 Setup Screens 3 1 Shutdown 10 12 Shuttle 1 10 Silicone compound 9 28 Smart modules Status 10 5 Sodium Azide preservative 2 vii Software version 3 23 Special calculations 3 20 Specifications system Clearances 1 2 Elevation 1 3 Operating temperature 1 3 STAT 3 14 Statistical summary report 7 10 Status Alarm Annunciator 3 32 See also ...

Page 496: ...uirements 8 1 Removing 8 19 Setup 3 24 8 3 V Valid entries 6 5 Version information 3 23 Version upgrade 3 31 W Warnings reagent and calibration status 4 15 Wash Concentrate II 9 10 Waste B pause resume 10 15 Wavelength Primary 8 6 8 15 Secondary 8 6 8 15 Westgard rules 5 2 5 3 Wheel See Carousel Wrist ground strap 9 43 ...

Page 497: ......

Page 498: ...nt to run most 20 test general chemistry panels UniCel DxC 600 and DxC 800 Synchron Clinical Systems In Lab Training Manual Used to train laboratory personnel on DxC 600 and 800 routine operations UniCel DxC 600 and DxC 800 Synchron Clinical Systems Operator Tips Provides a summary of frequently used information about your system and the chemistries used UniCel DxC Synchron Clinical Systems Host I...

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