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Abbott AEROSET, Troubleshooting Manual

Introducing Abbott AEROSET - an innovative troubleshooting manual designed to enhance your product experience. Accessible for free download via our website, this comprehensive manual equips users with step-by-step instructions and solutions to common issues. Visit manualshive.com to simplify your AEROSET experience with ease and convenience.

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System

Troubleshooting

Guide

Abbott Laboratories
Abbott Park, IL 60064
94816-107—November 2004

©1998, 2004 Abbott Laboratories

AEROSET is a Registered Trademark of

Abbott Laboratories

Summary of Contents for AEROSET

Page 1: ...System Troubleshooting Guide Abbott Laboratories Abbott Park IL 60064 94816 107 November 2004 1998 2004 Abbott Laboratories AEROSET is a Registered Trademark of Abbott Laboratories ...

Page 2: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution 2 AEROSET System Troubleshooting Guide 94816 107 November 2004 NOTES ...

Page 3: ... Section s Revised Pages Revised and Added 30 0897 R1 9 98 Original Issue Original Issue 30 1762 R2 1 00 All Sections All Pages 94816 101 6 01 All Sections All Pages 94816 102 4 02 All Sections All Pages 94816 103 6 02 All Sections All Pages 94816 104 2 03 All Sections All Pages 94816 105 6 03 All Sections All Pages 94816 106 12 03 All Sections All Pages 94816 107 11 04 All Sections All Pages ...

Page 4: ... specific Information subsections 1 If troubleshooting information for a specific assay is available it is listed alphabetically in Assay specific Information If an assay specific subsection does not exist no additional troubleshooting information is currently available 2 Previously some assays e g MULTIGENT assays included Assay specific Questions sections These Question and Answer sections were ...

Page 5: ...id Factor assays added to Assays Reagents Assay specific Information Information for the MULTIGENT Microalbumin assay added to Assays Reagents Assay specific Information The chemical reaction for MULTIGENT Microalbumin added to Chemical Reactions for Clinical Chemistry Assays New information for the Specific Proteins assays added to both the Assays Reagents General Information and Assays Reagents ...

Page 6: ...en converting units from mEq L to mg dL Software section new screen graphics with software version 1 03ER000 This includes SYSTEM CONFIGURATION screen PAGE SETUP screen Form 1 and Form 2 Log On screens two Assay Configuration screen Rerun Rules page MAINTENANCE UTILITIES screen SW Info page MAINTENANCE UTILITIES screen Sampling page Pressure Monitor screen Updated Unit Configuration screen default...

Page 7: ...1 Assay Configuration Installation 21 Drugs of Abuse DOA Assays 21 Cutoff Calibrator Values 21 Qualitative Assay Configuration 22 Print Options 23 Factor Mode Numeric Results 23 Example of Factor Mode Numeric Results Printout 25 Factor Mode POS NEG Results 26 Example of Factor Mode POS NEG Results Printout 28 Absorbance Mode 29 Example of Absorbance Mode Results Printout 31 Summary of Print Option...

Page 8: ...Survey 71 Immunology 71 Therapeutic Drug Monitoring 72 Urine Drug Testing Drugs of Abuse 72 Quality Control 73 Bio Rad Control Products 73 Ordering Information 76 Bio Rad 76 Biochemical Diagnostics Inc 76 Establishing Quality Control Limits 77 Temporary Quality Control Limits 77 Permanent Control Limits 78 Temporary Control Limits Worksheet 79 Reagent Test Count Tracking 80 Reagent Test Counts 80 ...

Page 9: ...ssays Data Sheet 98 Limit of Quantitation for Abbott Assays Data Sheet Example 99 Assay specific Information 101 Acid Phosphatase 101 Method Comparison 101 Albumin BCG 103 Calibrators 103 Observed Problem 103 Alkaline Phosphatase 103 Observed Problem 103 ALT 104 Ammonium Heparin Tube Not Acceptable 104 ALT AST Activated Versus ALT AST 104 Differences 104 ALT Activated 104 Ammonium Heparin Tube Not...

Page 10: ...Performed on the AEROSET System by SYVA 117 Complement C3 119 Observed Problems 119 Complement C4 120 Observed Problems 120 C Reactive Protein 121 Standard Material Recovery 121 Frequently Asked Questions FAQ 121 Creatine Kinase 125 Digoxin MULTIGENT 125 Spironolactone Canrenone Interference Results 125 Cross Reactivity 126 Sample Carryover 127 Frequently Asked Questions FAQ 127 Direct LDL MULTIGE...

Page 11: ...enerated 143 Immunoglobulin A 144 Observed Problems 144 Immunoglobulin G 145 Observed Problems 145 Immunoglobulin M 146 Observed Problems 146 Iron 148 Interference Information 148 Magnesium 149 Units Conversion 149 Methadone 151 Cross Reactivity Testing Performed on the AEROSET System by SYVA 151 Microalbumin MULTIGENT 152 Specimen Storage 152 Frequently Asked Questions FAQ 152 Opiates 300 153 Cro...

Page 12: ...Host Interface Trace Log 175 Observed Problems Software 176 QUALITY Control 178 Interval QC 178 QC Rounding 178 QC Statistics Decimal Places 179 Rounding of Numbers 180 Sample Sequence Smart Sampling 180 Screen Hierarchy 181 Action Area of the Main Display 181 Information Access Area of the Main Display 182 Screen Navigation 183 Main Display 183 REAGENTS Screen 183 REAGENTS Supply Center Segment S...

Page 13: ...Screen 198 ASSAY STATUS Screen 198 Assay Configuration Screen Outline Page 199 Assay Configuration Screen Base Page End point Assay 199 Assay Configuration Screen Base Page Rate Assay 200 Assay Configuration Screen Calibration Page Linear Calibration Mode 200 Assay Configuration Screen SmartWash Page 201 Assay Configuration Screen Rerun Rules Page 201 RUN OPTIONS Screen 202 SYSTEM CONFIGURATION Sc...

Page 14: ...tware Version 1 03ER000 216 Startup Shutdown Setting Default Screens 217 User Codes Passwords 219 Hardware 221 CPU Used with the AEROSET System 223 Cuvettes 225 Cuvette Volumes Minimum and Maximum 225 Cuvette Warranty 225 Cuvette Identification 225 GPIB 226 ICT Warranty Information 226 Noise Specifications 226 Observed Problems Hardware 227 Serial Numbers 230 Specifications 231 Water 231 USP Purif...

Page 15: ...Assay Basic Assay Troubleshooting 247 Assay Characteristics 248 Instrument Troubleshooting 248 Non Abbott Assay Basic Assay Troubleshooting 250 Confirmation of Assay Parameter Settings Illegal Configuration 251 Erratic Results 253 QC Out of Range 254 Calibration Errors 257 ICT Failed Calibration 259 Bubbles in ICT Module Tubing 261 LIS Communication Problems 262 Water Issue 264 ...

Page 16: ...eloped for use by trained Abbott Laboratories Field Service personnel or by other persons knowledgeable or experienced with operation and service of the AEROSET System The information should be used under direct supervision and cooperation with Abbott Laboratories technical sales and service representatives In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses...

Page 17: ...rademark trade name trade dress or product name may be made without the prior written authorization of Abbott Laboratories except to identify the product or services of Abbott Laboratories All other trademarks brands product names and trade names are the property of their respective companies All rights reserved Except as permitted above no license or right express or implied is granted to any per...

Page 18: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution 18 AEROSET System Troubleshooting Guide 94816 107 November 2004 NOTES ...

Page 19: ...AEROSET System Troubleshooting Guide 19 94816 107 November 2004 Assays Reagents Assays Reagents ...

Page 20: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays Reagents Not for Customer Distribution 20 AEROSET System Troubleshooting Guide 94816 107 November 2004 NOTES ...

Page 21: ...tes Phencyclidine and Propoxyphene Cutoff Calibrator Values Cutoff calibrator levels used for each of the qualitative DOA assays are listed in the following table Cutoff concentrations mandated by SAMHSA Substance Abuse and Mental Health Services Administration for Federal Workplace drug testing The Ethanol assay is a quantitative assay which is calibrated using two levels of calibrator 0 mg dL an...

Page 22: ...d assay button The ASSAY STATUS screen displays 3 Select Config in the right column of the screen The Assay Configuration screen displays 4 The Outline page is the default view 5 Verify Quantitative Ranges is selected This is the default setting 6 Edit the L Reference field from 9999 to 0 0 7 Select the Calibration tab to access the Calibration page 8 Select the list box icon next to the Calib Mod...

Page 23: ...f calibrator and a negative number for a value lower than the Multi DOA Cutoff calibrator A positive number is interpreted as positive the specimen contains drug A negative number is interpreted as negative the specimen does not contain drug or drug present yields a response less than that of the cutoff concentration for the assay being tested NOTE Positive and negative numeric response values do ...

Page 24: ... is selected 聺 This is the default setting 6 Select the Calibration tab to access the Calibration page Figure 2 Assay Configuration Screen Calibration Page 7 Verify the Factor option is selected in the Calib Mode field 8 Verify 1000 is entered in the Factor field 9 Select OK in the upper right corner of the Assay Configuration screen The Save dialog window displays 10 Select OK to save the setting...

Page 25: ...out The Barbiturates assay in this example would be reported as positive Phencyclidine Propoxyphene Opiates 300 Methadone Amphetamine Methamphetamine Cocaine and Benzodiazepines would be reported as negative 10 17 01 13 01 SN A7602220 SID 007 Name John Doe POS 5 2 PID Date Time Run 10 17 01 13 01 ERR NAME L H RESULT ERR NAME L H RESULT PCP 30 AmpM 36 Prpx 52 Coc 16 Opi3 17 Benz 24 Meth 30 Barb H 1...

Page 26: ... result is interpreted as negative the specimen does not contain drug or drugs are present in concentrations below the cutoff level for the assay being tested Perform the following steps to configure an assay in Factor mode 1 Select Assays in the Information Access Area of the Main Display The ASSAYS screen displays 2 Select the desired assay button The ASSAY STATUS screen displays 3 Select Config...

Page 27: ...ccess the Calibration page Figure 4 Assay Configuration Screen Calibration Page 7 Verify the Factor option is selected in the Calib Mode field 8 Verify 1000 is entered in the Factor field 9 Select OK in the upper right corner of the Assay Configuration screen The Save dialog window displays 10 Select OK to save the settings 11 Repeat steps 1 through 10 for each DOA assay installed Factor ...

Page 28: ...is example would be reported as positive Phencyclidine Propoxyphene Opiates 300 Methadone Amphetamine Methamphetamine Cocaine and Benzodiazepines would be reported as negative NOTE A result of 0 would be reported as a positive result 10 17 01 13 01 SN A7602220 SID 007 Name John Doe POS 5 2 PID Date Time Run 10 17 01 13 01 ERR NAME L H RESULT ERR NAME L H RESULT PCP NEG AmpM NEG Prpx NEG Coc NEG Op...

Page 29: ...ue lower than the Multi DOA Cutoff calibrator absorbance Perform the following steps to configure an assay in Absorbance mode 1 Select Assays in the Information Access Area of the Main Display The ASSAYS screen displays 2 Select the desired assay button The ASSAY STATUS screen displays 3 Select Config in the right column of the screen The Assay Configuration screen displays 4 The Outline page is t...

Page 30: ...cess the Calibration page Figure 6 Assay Configuration Screen Calibration Page 8 Select the list box icon next to the Calib Mode field Select Abs then select the return arrow to close the list 9 Select OK in the upper right corner of the Assay Configuration screen The Save dialog window displays 10 Select OK to save the settings 11 Repeat steps 1 through 10 for each DOA assay installed Abs ...

Page 31: ...es Cocaine Methadone Opiates 300 Opiates 2 000 Phencyclidine and Propoxyphene would be reported as negative 10 17 01 13 01 SN A7602220 SID 007 Name John Doe POS 5 2 PID Date Time Run 10 17 01 13 01 ERR NAME L H RESULT ERR NAME L H RESULT PCP 0 3237 AmpM 0 2776 Prpx 0 3870 Coc 0 3212 Opi3 0 2341 Benz 0 2702 Meth 0 3988 Barb 0 2926 Assay Sample Absorbance Cutoff Absorbance Result Amphetamine Methamp...

Page 32: ...T ASSAYS FOR CALIBRATION screen Calibration Summary report does not print the ICT Cal L values Print Options Description of Results Outline Page Configuration Calibration Page Configuration Factor Mode Numeric Results Positive or negative numbers will print numbers are relative to the cutoff calibrator and do not represent actual concentration Select Quantitative Ranges Calib Mode Factor Factor 1 ...

Page 33: ...aste disposal regulations For additional environmental health and safety information refer to Section 8 Hazards of the AEROSET System Operations Manual and the product specific package insert Mercury Warning Symbol Because mercury is a persistent and toxic pollutant that bioaccumulates in the environment several states have enacted legislation which impacts the marketing and labeling of products c...

Page 34: ...say s rerun data to the original data and to perform recalculation of the ratio 1 On the DATABASE screen select the rerun sample rerun sample has the Processing Code L 2 Select Result in the right column of the DATABASE screen The RESULT screen displays 3 Display the desired rerun result 4 Select Select in the right column of the RESULT screen 5 Select OK on the Select Result dialog window An S di...

Page 35: ...e Opiates 300 assay For Amphetamine Methamphetamine Barbiturates Benzodiazepines Cannabinoids THC50 Cocaine Methadone Opiates 300 Opiates 2 000 Phencyclidine and Propoxyphene assays any result value equal to or greater than the Multi DOA Cutoff calibrator is positive the specimen contains drug Any result below the cutoff level for the assay being tested is interpreted as negative the specimen does...

Page 36: ...does not interfere with the Opiates 300 assay Refer to the assay specific package inserts for additional information on calibration verifiers and controls Assay Drug Multi DOA Verifier I ng mL Opiates 300 Cal ng mL Multi DOA Cutoff Cal ng mL Multi DOA Verifier II ng mL Amphetamine Methamphetamine d Methamphetamine 0 300 1 000 2 000 Barbiturates Secobarbital 0 200 800 Benzodiazepines Lormetazepam 0...

Page 37: ...le because the enzyme reaction occurs at a predictable and steady rate that can be determined for the chromophore wavelengths and volume parameters used Enzyme Factor Calculation The following formula is used to calculate enzyme factors Where Total Volume Reagent 1 volume Reagent 1 water volume Reagent 2 volume Reagent 2 water volume Sample volume Extinction factor established by measuring varying...

Page 38: ...r to this calibration data for result calculation For example a urine application of an assay may use the calibration data generated for the serum application for the same assay e g urine Amylase The assay selected as the reference assay must generate its own curve and cannot also be defined with the Use Factor Blank calibration mode Assay Chromophore Wavelength Total Volume µL Sample Volume µL Ex...

Page 39: ...uct Name List Number Configuration Assays Multiconstituent 1E65 02 CAL 1 3 x 5 mL CAL 2 3 x 5 mL Alb Ca Chol Crea Crea U Glu Glu U Phos Phos U TP Trig UPro Urea Urea U Uric MCC DOA Cutoff 2G90 02 1 x 14 mL AmpM Barb Benz Coc Meth Opi2 PCP Prpx THC50 Apo Al Apo B 6E54 02 1 x 1 mL ApoA ApoB Bilirubin 1E66 03 CAL 1 3 x 5 mL CAL 2 3 x 5 mL BilD BilN BilT C Reactive Protein 8G68 02 CAL 1 1 x 2 mL CAL 2...

Page 40: ...L ETOH HDL 1E68 02 6 x 1 mL HDL Hemoglobin A1c 2K96 02 CAL 1 1 x 8 mL CAL 2 1 x 2 mL CAL 3 1 x 2 mL CAL 4 1 x 2 mL CAL 5 1 x 2 mL CAL 6 1 x 2 mL HbA1c ICT Serum 1E46 02 CAL 1 5 x 10 mL CAL 2 5 x 10 mL Na K Cl ICT Urine 1E47 02 URINE CAL L 5 x 10 mL URINE CAL H 5 x 10 mL Na U K U Cl U Iron Magnesium 1E69 02 CAL 1 3 x 5 mL CAL 2 3 x 5 mL Iron Mg TIBC Lactic Acid 1E75 02 1 x 10 mL Lact Lipase 3E16 02...

Page 41: ...x 1 mL CAL 2 1 x 1 mL CAL 3 1 x 1 mL CAL 4 1 x 1 mL CAL 5 1 x 1 mL RF Specific Proteins Multiconstituent 1E78 02 CAL 1 1 x 1 mL CAL 2 1 x 1 mL CAL 3 1 x 1 mL CAL 4 1 x 1 mL CAL 5 1 x 1 mL C3 C4 Hapt IgA IgG IgM TRF Theophylline 6E89 02 CAL 1 1 x 5 mL CAL 2 1 x 2 mL CAL 3 1 x 2 mL CAL 4 1 x 2 mL CAL 5 1 x 2 mL CAL 6 1 x 2 mL Theo Urine CSF Protein 1E71 02 CAL 1 1 x 5 mL CAL 2 1 x 5 mL CAL 3 1 x 5 m...

Page 42: ...or frozen Calibration is stable for approximately five days and performed using a water blank Sample Interference Indices may assist with determination of sample integrity AlbG BCG Albumin BCG Colored complex BCG Bromcresol green Results are running high due to non specific protein binding Recommend AlbP if more specificity needed AlbP BCP Human Albumin BCP Colored complex BCP Bromcresol purple Hu...

Page 43: ... PD Glucose 6 phosphate dehydrogenase from bacterial source NADH Nicotinamide adenine dinucleotide Use Multi DOA Cutoff calibrator in duplicate for calibration Cutoff calibrator value is zero on CALIBRATOR CONTROL screen Amy 10 CNPG3 9 CNP 1 CNPG2 CNPG3 2 chloro 4 nitrophenyl α D maltotrioside Chromophore is 2 chloro 4 nitrophenol CNP read at 404 nm ApoA Apo A1 PEG buffer R1 Antibody to Apo A1 R2 ...

Page 44: ...H 6 phosphogluconate G 6 PD Glucose 6 phosphate dehydrogenase from bacterial source NADH Nicotinamide adenine dinucleotide Use Multi DOA Cutoff calibrator in duplicate for calibration Cutoff calibrator value is zero on CALIBRATOR CONTROL screen Benz Antibody to Benzodiazepines R1 G 6 PD Benzodiazepines R2 Active G 6 PD Benzodiazepines Antibody complex Inactive G 6 PD Benzodiazepines Antibody compl...

Page 45: ...henyl diazonium salt Azobilirubin The formation of azobilirubin is measured spectrophoto metrically and is directly proportional to the concentration of bilirubin Avoid hemolysis during sample collection Protect samples from light Same formulation as LN 2K58 20 C3 Complement C3 PEG buffer R1 Antibody to C3 R2 Turbidity due to C3 Antibody complex PEG Polyethylene glycol C4 Complement C4 PEG buffer ...

Page 46: ...s empty replace both cartridges and validate the system by analyzing controls Chol Cholesterol esters H2O Cholesterol fatty acids Cholesterol O2 Cholest 4 ene 3 one H2O2 2H2O2 HBA 4 AAP Quinoneimine dye 4H2O CE Cholesterol esterase CO Cholesterol oxidase 4 AAP 4 Aminoantipyrine HBA Hydroxybenzoic acid POD Peroxidase According to the National Cholesterol Education Program NCEP patients need not be ...

Page 47: ... Cocaine R1 G 6 PD Cocaine R2 Active G 6 PD Cocaine Antibody complex Inactive G 6 PD Cocaine Antibody complex Inactive Cocaine G 6 PD Cocaine Active Cocaine Antibody complex G 6 PD Cocaine Active NAD Glucose 6 phosphate NADH 6 phosphogluconate G 6 PD Glucose 6 phosphate dehydrogenase from bacterial source NADH Nicotinamide adenine dinucleotide Use Multi DOA Cutoff calibrator in duplicate for calib...

Page 48: ...IL LN 2K59 20 DCL Label Direct Bilirubin 2 4 Dichlorophenyl diazonium salt Azobilirubin The formation of azobilirubin is measured spectrophoto metrically and is directly proportional to the concentration of bilirubin Avoid hemolysis during sample collection Protect samples from light Same formulation as LN 8G63 20 Dig Digoxin Antibody to Digoxin BIS TRIS buffer R1 Digoxin coated Microparticles R2 ...

Page 49: ...l 3 carboxy 4 nitroanilide glycylglycine L γ glutamyl glycylglycine 3 carboxy 4 nitroaniline The Roche GGT assay on the Roche Hitachi 717 has approximately a 30 low bias compared to the AEROSET System Abbott has documentation to support this bias and the accuracy of the AEROSET values The AEROSET methodology utilizes the IFCC method Glu Glucose ATP Glucose 6 Phosphate ADP Glucose 6 phosphate NADP ...

Page 50: ...HDL HDL LDL VLDL Chylomicrons Stable complexes HDL HDL Disrupted HDL Cholesterol 4 Cholestenone H2O2 H2O2 DSBmT 4 AAP Quinoneimine Dye H2O DSBmT N N bis 4 sulphobutyl m toluidine disodium 4 AAP 4 Aminoantipyrine Linearity and control material must be human based material IgA IgA PEG buffer R1 Antibody to IgA R2 Turbidity due to IgA Antibody complex PEG Polyethylene glycol IgG IgG PEG buffer R1 Ant...

Page 51: ...ens should be obtained without the use of a tourniquet or immediately after the tourniquet is applied Specimen must be collected using a fluoride oxalate tube centrifuged as soon after collection as possible and immediately remove the plasma from the red blood cells Calibration is required each time a new reagent is reconstituted LD L lactate NAD Pyruvate NADH H NADH Nicotinamide adenine dinucleot...

Page 52: ...O 4 AAP 4 Aminoantipyrine TOOS N ethyl N 2 hydroxy 3 sulfopropyl m toluidine There are reports of interference by non Abbott HDL methods Correct SmartWash configuration is critical for some assays Serum only Must not be on the same line as Triglyceride Calcium Urine Calcium Cholesterol CO2 MULTIGENT LDL and Uric Acid Meth Antibody to Methadone R1 G 6 PD Methadone R2 Active G 6 PD Methadone Antibod...

Page 53: ...Active G 6 PD Opiates Antibody complex Inactive G 6 PD Opiates Antibody complex Inactive Opiates G 6 PD Opiates Active Opiates Antibody complex G 6 PD Opiates Active NAD Glucose 6 phosphate NADH 6 phosphogluconate G 6 PD Glucose 6 phosphate dehydrogenase from bacterial source NADH Nicotinamide adenine dinucleotide Opiates 300 Use Opiates 300 calibrator in duplicate for calibration Calibrator value...

Page 54: ...nactive Phenobarbital G 6 PD Phenobarbital Active Phenobarbital Antibody complex G 6 PD Phenobarbital Active NAD Glucose 6 phosphate NADH 6 phosphogluconate G 6 PD Glucose 6 phosphate dehydrogenase from bacterial source NADH Nicotinamide adenine dinucleotide Blank this assay with Pheno CAL 1 When either the R1 or R2 reagent cartridge is empty replace both cartridges and validate the system by anal...

Page 55: ...osphate NADH 6 phosphogluconate G 6 PD Glucose 6 phosphate dehydrogenase from bacterial source NADH Nicotinamide adenine dinucleotide Use Multi DOA Cutoff calibrator in duplicate for calibration Cutoff calibrator value is zero on CALIBRATOR CONTROL screen RF RF Sample Buffer R1 Antibody to RF adsorbed to latex particles R2 Turbidity due to agglutination of RF Antibody Particle complex TBil LN 7D60...

Page 56: ...e adenine dinucleotide Use Multi DOA Cutoff calibrator in duplicate for calibration Cutoff calibrator value is zero on CALIBRATOR CONTROL screen Certain types of plastics adsorb cannabinoids THC from solutions decreasing the concentration To prevent adsorbtion Fill AEROSET sample cups with 600 µL to minimize surface to volume ratio Do not use disposable polyethylene transfer pipettes to dispense u...

Page 57: ...tridges and validate the system by analyzing controls TIBC Apotransferrin excess Fe 3 Fe transferrin Fe 3 Fe 3 Fe transferrin alumina Eluent of Fe transferrin analyzed using Iron Reagent LN 7D68 Serum only TOBIL LN 2K58 20 DCL Label Total Conjugated Unconjugated Bilirubin 2 4 Dichlorophenyl diazonium salt Azobilirubin The formation of azobilirubin is measured spectrophoto metrically and is directl...

Page 58: ...onfigured on the Assay Configuration screen is defined as 1 because the software does not allow for a sign reference value Must not be on the same line as the Lipase assay Hyperlipemic samples require a dilution to be performed to ensure accurate results uAlb Microalbumin Good s buffer R1 TRIS buffer R2 Anti human albumin goat antibody R2 Turbidity due to Microalbumin Anti human albumin goat antib...

Page 59: ...tly Sigma linearity standards recover at approximately 50 for the highest level on the AEROSET System The same is seen with Roche assays run on the Roche Hitachi Verichem linearity was able to recover at 100 VPA Valproic Acid Antibody to Valproic Acid BIS TRIS buffer R1 Valproic Acid coated Microparticles R2 Valproic Acid Antibody complex Valproic Acid coated Microparticle Antibody complex Valproi...

Page 60: ... Barbs Downers Capsules tablets Parent compounds of each with hydroxy metabolite Benzodiazepines Valium diazepam Tranxene clorazepate Librium chlordiazepoxide Serax oxazepam Dalmane flurazepam Ativan lorazepam Xanax alprazolam Versed Halcion Restoril Benzos mellow Mickey Finn when used with alcohol Powder capsules tablets Oxazepam for diazepam and chlordiazepoxide Cannabinoids Marinol dronabinol T...

Page 61: ...mack Horse White Lady Skag H Morphine Junk White Stuff Morpho M Other analgesics anti tussives Heroin brown to white powder Morphine small white tablets or powder injectable form Other tablets liquid powder and injectable forms Heroin Morphine Morphine Morphine Other Codeine to morphine parent compound Phencyclidine None Angel Dust Hog Killer Weed when used on marijuana Fine white powder PCP and m...

Page 62: ...iratory collapse loss of consciousness Chronic addiction Abstinence seizures death Deadly when combined with alcohol Benzodiazepines Taken orally Flurazepam 1 to 2 days Oxazepam etc 2 to 7 days Laid back mellow personality mental confusion Acute intoxication loss of inhibitions Chronic addiction involuntary muscle movements of the face limbs and trunk tardive dyskinesia Cannabinoids Smoked as ciga...

Page 63: ... Taken orally Dose dependent up to 24 hours Mental confusion vomiting blackouts personality change when drinking Acute intoxication hangover vomiting death Chronic abstinence seizures addiction inflammation of stomach lining gastritis inflammation of liver hepatitis inflammation of pancreas pancreatitis death Methadone Taken orally 14 days Acute abnormal sense of well being euphoria Good sick naus...

Page 64: ...n GI symptoms discomfort agitation Addiction overdose death Phencyclidine Smoked on marijuana taken intravenously or orally Up to 10 days Aggressive behavior combativeness involuntary rhythmic movements of eyes nystagmus uncoordinated movement ataxia Aggressive and dangerous behavior persistently elevated blood pressure hypertension seizures involuntary muscle contractions spasms Propoxyphene Oral...

Page 65: ... should cover the entire assay range with particular emphasis at the cutoff concentration All discrepant data points between the AEROSET DOA assay and comparative method should be investigated further by GC MS to confirm the results Because the Ethanol assay is a quantitative assay routine method comparison studies should be performed Serum and urine samples known to be free from interfering subst...

Page 66: ...ULTIGENT assay menu including OEM supplier information is listed in the following table Manufacturer Information Seradyn Inc 7998 Georgetown Road Suite 1000 Indianapolis IN 46268 800 428 4072 317 610 3828 www seradyn com Genzyme Diagnostics One Kendall Square Cambridge MA 02139 1562 800 332 1042 617 252 7500 www genzymediagnostics com Wako Chemicals USA Inc 1600 Bellwood Road Richmond VA 877 714 1...

Page 67: ...Plasma Claims for Gel Barrier Tubes For assays that allow plasma as a suitable specimen the following statement appears in the package insert Use plasma collected by standard venipuncture techniques in glass or plastic tubes without gel barrier Clarification plasma tubes with a gel barrier were not tested therefore no claim is made for these types of tubes ...

Page 68: ...bin Total LN 7D60 147 Abbott oxidation Calcium 135 Abbott arsenazo III Chloride 135 Abbott diluted ISE Cholesterol Total 146 Abbott Creatine Kinase CK 146 Abbott NAC 37 C Creatinine 135 Abbott nonenzymatic rate GGT 146 Abbott IFCC substrate 37 C Glucose 142 Abbott hexokinase 340 nm HDL Cholesterol 135 Abbott direct homogeneous Iron 146 Abbott FERENE based Lactate Dehydrogenase LD 135 Abbott L P 37...

Page 69: ... Apolipoprotein B 1241 Immunoturbidimetric AST 1518 Abbott 37 C AST Activated 1526 Abbott pyridoxal phosphate activated reagent 37 C Bilirubin Direct LN 7D59 1764 Oxidation Bilirubin Direct LN 2K59 DCL 1114 Diazo caffeine benzoate coupling Jendrassik Grof with blank Bilirubin Neonatal 1120 Spectrophotometric without blank Bilirubin Total LN 7D60 1764 Oxidation Bilirubin Total LN 2K58 DCL 1114 Diaz...

Page 70: ... of lactate to pyruvate automated LDL Direct 1757 Liquid select detergent Equal Genzyme Pointe ThermoTRACE Lipase 1518 Abbott 37 C Magnesium 1763 Arsenazo Phosphorus 1216 Phosphomolybdate UV Potassium 1227 Ion selective diluted indirect Prealbumin 3254 Abbott AEROSET Protein Total 1217 Biuret Sodium 1227 Ion selective diluted indirect TIBC 1018 Alumina adsorption Transferrin 3254 Abbott AEROSET Tr...

Page 71: ...um 1227 Ion selective electrode diluted indirect Urea 1253 Urease with GLDH coupled enzyme Uric Acid 1262 Uricase Urine CSF Protein 0010 Other method specify on result form MULTIGENT assay Analyte CAP Code Methodology Glucose 1172 Hexokinase UV Urine CSF Protein 0010 Other method specify on result form Analyte CAP Code Methodology C Reactive Protein 1637 Turbidimetric immunoturbidimetric Complemen...

Page 72: ...t AEROSET Phenobarbital 3254 Abbott AEROSET Phenytoin 3254 Abbott AEROSET Theophylline 3254 Abbott AEROSET Valproic Acid 3254 Abbott AEROSET MULTIGENT assay Analyte CAP Code Methodology Amphetamine Methamphetamine 1031 EIA EMIT Barbiturates 1031 EIA EMIT Benzodiazepines 1031 EIA EMIT Cannabinoids 1031 EIA EMIT Cocaine 1031 EIA EMIT Methadone 1031 EIA EMIT Opiates 300 1031 EIA EMIT Opiates 2 000 10...

Page 73: ...yed Chemistry Control L 1 C 310 5 L 2 C 315 5 12 x 5 mL 12 x 5 mL ACP Alb AlkP ALT Amy ApoA ApoB AST BilD BilT C3 C4 Ca Carb Chol CK Cl CO2 Crea Dig GGT Glu Hapt IgA IgG IgM Iron K Lact LD Lip Mg Na Pheno Pheny Phos Theo TIBC TP TRF Trig Urea Uric VPA Liquid Assayed Multiqual Chemistry Control L 1 694 L 2 695 L 3 696 12 x 3 mL 12 x 3 mL 12 x 3 mL ACP Alb AlkP ALT Amy ApoA ApoB AST BilD BilN BilT C...

Page 74: ... 595 L 3 596 6 x 1 mL 6 x 1 mL 6 x 1 mL 6 x 3 mL 6 x 3 mL 6 x 3 mL Alb ApoA ApoB C3 C4 CRP Hapt IgA IgG IgM PAlb RF TP TRF Liquichek Urine Chemistry Control L 1 397 L 2 398 12 x 10 mL 12 x 10 mL Amy Ca Cl Crea Glu K Mg Na Phos TP uAlb Urea Uric Lyphochek Quantitative Urine Control L 1 376 L 2 377 12 x 10 mL 12 x 10 mL Barb Ca Cl Crea Glu Iron Mg Na Phos TP uAlb Urea Uric Liquichek Rheumatoid Facto...

Page 75: ...4 Positive 455 6 x 3 mL 6 x 3 mL AmpM Barb Benz Coc ETOH Meth PCP Prpx THC Liquichek Immunology Plus Control Trilevel 360 L 1 361 L 2 362 L 3 363 12 x 5 mL 4 ea 12 x 5 mL 12 x 5 mL Carb Dig Iron Pheno Pheny Theo VPA Liquichek Therapeutic Drug Monitoring Control Trilevel 724 L 1 725 L 2 726 L 3 727 12 x 5 mL 12 x 5 mL 12 x 5 mL Carb Dig Pheno Pheny Theo VPA Control Product Name Catalog Number Confi...

Page 76: ...his lot of control The tests listed were performed by the reagent manufacturer and or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of control Individual laboratory means should fall within the corresponding acceptable range however the values listed may vary during the life of this control Variations over time and between laboratories may...

Page 77: ...d controls to each analyzer cup for each new run 4 Calculate the mean for each control level and record it on the worksheet Multiply each mean by 0 20 and record the result 20 of the mean on the worksheet 5 Determine the temporary control limits for each control level 20 of each mean control concentration For example if the mean control concentration of Theophylline is 10 µg mL the control limits ...

Page 78: ...ntrols are within the temporary control limits test patient samples b If the control is still not within its control limits reject the run and recalibrate Run controls again After recalibration if the controls are within their control limits accept the run c If the control is still not within its control limits reject the run then recalibrate Run controls again After recalibration if the controls ...

Page 79: ...___________ Control 1 _________________________________________________ Lot _______________________ Control 2 _________________________________________________ Lot _______________________ Control 3 _________________________________________________ Lot _______________________ Temporary control limits accepted by Name ____________________________________________________ Date _______________________ ...

Page 80: ...ys For example assays with both a serum and urine application such as Glucose and Creatinine use the same reagent cartridge but have different assay numbers The total number of tests is divided by two half for the serum assay and half for the urine assay In house studies have validated the number of estimated tests per kit included in the assay specific Abbott Clinical Chemistry Package Inserts Ho...

Page 81: ... Self Blank A separate assay parameter file is defined to measure the blank reading All parameters must be defined as if it was a stand alone assay This stand alone blank assay should have nothing selected in the Sample Blank Test field or in the Blank Read Time field For example for the blank test you could use saline or water and sample On the Base page of the Assay Configuration screen of the a...

Page 82: ...arameters The operator can choose between semi quantitative i e Index units or qualitative 0 1 2 3 4 results format To estimate hemolysis icterus and lipemia on a sample a reference photometric assay file must be configured To configure this file the operator must define which reagent saline ALT or AST to use for the analysis Package inserts are available for both the Saline and the ALT AST Protoc...

Page 83: ...he reagent carryover SmartWash Things to consider 1 When an assay is defined in the B Line the SmartWash page only allows selection of a reagent probe wash with other assays in the B Line These reagent probe washes are defined for the Abbott assays If the assay is moved to the A Line the assay may be affected by carryover from an assay in the A Line Refer to the assay specific or Abbott Clinical C...

Page 84: ...cted assay the reagent probe aspirates the required volume of wash solution to clean the probe between the assays and dispenses wash solution into an empty cuvette to also clean the mixer s An extra cuvette is used for this procedure When a SmartWash is configured for the reaction cuvette wash solution is added to the cuvette to minimize reagent interference This decreases the assay throughput fro...

Page 85: ...precision concerns verify R2 mixer alignment and function R2 reagent probe dispense and position and proper installation of R2 reagent syringe seal tips and O ring Bar Code Read Errors Round bottles may rotate slightly in adapters when the Reagent Carousel rotates moving the bar code label and affecting the ability of the bar code scanner to read the bar code label Turn the reagent bottle toward t...

Page 86: ...les will exceed the highest calibrator concentration Why are calibration modes for ApoA ApoB and PAlb linear if the calibration curves are not straight Although the graphs appear non linear for these assays the calibrations approximate a linear response close enough to ensure accurate results across the calibration range Therefore the calibration modes were defined as linear for each of these assa...

Page 87: ...on to determine the result Why are the linear low and LOQ different values LOQ is the lowest analyte concentration at which CV 20 Some Specific Proteins assays become increasingly inaccurate as analyte concentrations drop below the lowest calibrator and approach the LOQ For this reason the linear low limits for these assays are based on accuracy by recovery studies not LOQ studies When running the...

Page 88: ... time period for as soon as possible Tietz Textbook of Clinical Chemistry 2nd ed uses the same verbiage but adds and certainly within two hours Reference Laessig RH et al Changes in serum chemical values as a result of prolonged contact with the clot Am J Clin Pathol 1986 Mon 66 598 604 Serum should be separated within two hours of collection and prolonged contact of serum with the clot will affec...

Page 89: ...nd each change in reagent lot number CAL 1 must always be used as the blank Do not use water to calibrate A Blank Adjustment calibration using CAL 1 is required once each day of assay use unless a full calibration is performed To obtain recommended volume requirements for the Abbott TDM calibrators hold the bottles vertically and dispense two drops 50 µL of each calibrator into each respective sam...

Page 90: ...e and to achieve 28 days reagent onboard stability and 14 days calibration stability Also this eliminates the need to recap reagent cartridges and place them back in the refrigerator which is necessary with other vendor products such as Olympus How is Abbott s precision claim determined Abbott s package insert claim for total precision is CV 7 for Carbamazepine and Phenobarbital and CV 8 for Pheny...

Page 91: ...ssay Phenytoin is extensively metabolized and the major pathway is para hydroxylation of the phenyl ring The resulting metabolite p hydroxyphenytoin HPPH is inactive and present largely as a glucuronide conjugate HPPG Both metabolites are structurally similar to phenytoin and may interfere with immunoassays This is especially true in renal insufficiency where HPPG clearance is decreased and plasma...

Page 92: ...The LOD is determined by analyzing a zero concentration sample saline or equivalent zero level material and adding two standard deviations SD to the mean of the results The LOD is the mean concentration of an analyte free sample 2 SD where SD equals the pooled within run standard deviation of the analyte free sample Before performing the study the following conditions must be met Maintenance proce...

Page 93: ...ered select New 4 Enter the following information Name or SID C P Replicates 5 5 Select the assay s to be evaluated 6 Select Copy in the right column of the Order Samples screen The Copy Order dialog window displays 7 Enter 1 in the How Many Copies field to request one copy N 10 2 samples 5 replicates then select OK The Order Samples screen displays 8 Load the sample s in the designated C P 9 Sele...

Page 94: ..._____________________________________ ________________________________________________________________________________________ Technologist _____________________________________________ Date _______________________ Reviewed by _____________________________________________ Date _______________________ Lot Number Expiration Date Reagent Kit Calibrators Replicate Value 1 2 3 4 5 6 7 8 9 10 A Determin...

Page 95: ...n _______________________________________________________________________________________ Technologist Name Date 3 11 03 Reviewed by Name Date 3 11 03 Lot Number Expiration Date Reagent Kit 334455MB 07 07 03 Calibrators 50383 05 01 03 Replicate Value 1 0 05 2 0 05 3 0 03 4 0 04 5 0 02 6 0 06 7 0 03 8 0 02 9 0 10 10 0 02 A Determine the mean of the replicates Mean 0 04 B Determine the SD of the rep...

Page 96: ... or second non zero calibrator to the approximate concentration of the LOQ stated in the insert For example the LOQ for AEROSET Carbamazepine is 0 5 µg mL The Level 2 calibrator first non zero calibrator contains 2 0 µg mL of analyte The following dilution can be prepared 1 4 dilution of the Level 2 calibrator resulting in a 0 5 µg mL sample for testing 2 Select Database in the Information Access ...

Page 97: ...ng Guide 97 94816 107 November 2004 8 Load the sample s in the designated C P 9 Select OK in the right column of the screen 10 Select RUN in the Action Area of the Main Display The RUN OPTIONS screen displays 11 Select the Patient option 聺 12 Select Start in the right column of the RUN OPTIONS screen to initiate the run ...

Page 98: ...________________________________________________________________________ ________________________________________________________________________________________ Technologist _____________________________________________ Date ________________________ Reviewed by _____________________________________________ Date _______________________ Lot Number Expiration Date Reagent Kit Calibrators Replicate V...

Page 99: ...s Confirmed limit of quantitation _______________________________________________________________________________________ Technologist Name Date 3 11 03 Reviewed by Name Date 3 11 03 Lot Number Expiration Date Reagent Kit 334455MB 07 07 03 Calibrators 50383 05 01 03 Replicate Value 1 0 25 2 0 25 3 0 25 4 0 23 5 0 20 6 0 26 7 0 24 8 0 35 9 0 35 10 0 25 A Determine the mean of the replicates Mean 0 ...

Page 100: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays Reagents Not for Customer Distribution 100 AEROSET System Troubleshooting Guide 94816 107 November 2004 NOTES ...

Page 101: ...in the following table Array and AEROSET values for ACP agree with each other as do the Vitros and Paramax but the Array AEROSET do not agree with Vitros Paramax ACP values for three other CAP specimens tested by Paramax and AEROSET demonstrate similar disparity 1 93 10 85 and 7 73 U L by Paramax 5 67 40 39 29 19 U L by AEROSET Method comparison data for AEROSET and Paramax yielded the following l...

Page 102: ...results The Paramax employs a solid tablet reagent format the Vitros a unique dry damp slide format and the Array and AEROSET both use liquid reagents The exact content of all of these reagents is not known this is proprietary information Given the many factors affecting ACP analysis such as heterogeneity of the enzyme different isozymes are found in liver spleen erythrocytes prostate etc differen...

Page 103: ...lkaline Phosphatase Observed Problem Illegal assay configuration Probable Cause s Corrective Action s Diluent not configured Ensure new assay parameters are installed Diluent is now necessary for calibration refer to Revision 3 or greater of the package insert Refer to Section 2 Installation Procedures and Special Requirements of the AEROSET System Operations Manual RL Result Error Code Probable C...

Page 104: ... ALT AST Differences ALT Activated and AST Activated assays contain the coenzyme activator pyridoxal 5 phosphate P 5 P ALT and AST assays do not contain P 5 P Most laboratories in the U S prefer non activated formulations while use of activated assays is prevalent in European laboratories The IVD Directive is encouraging laboratories to use activated forms of the reagent There is no difference in ...

Page 105: ...0 ng mL d methamphetamine Multi DOA Cutoff calibrator when tested at the concentration listed Compound SYVA Package Insert µg mL Acetaminophen 1 000 Acetylsalicylic acid 1 000 Alpha acetyl N N dinormethadol dinor LAAM 25 l Alpha acetylmethodol LAAM 25 Buprenorphine 100 Caffeine 1 000 Clomipramine 2 5 Clonidine 1 000 Codeine 500 Cotinine 100 Cyclobenzaprine 28 Doxepin 10 Glutethimide 500 Ketamine 1...

Page 106: ...ethod used on the AEROSET System In addition the mechanism of the reported amylase inhibition may not affect all amylase assays Until specific information is available for the AEROSET amylase results from patients receiving peritoneal dialysis must be assessed in relation to their clinical condition and exposure to icodextrin Wang G Leesch V Turner P Moberly JB Martis L Kinetic analysis of icodext...

Page 107: ...ited to high calibrator concentration Edit the Linear Range H field to the high calibrator concentration as stated in the calibrator value sheet Poor precision or erroneous results Probable Cause s Corrective Action s R2 reagent arm is out of alignment Adjust the R2 reagent arm Refer to Reagent Arm Adjustment in the Hardware section of this guide R2 reagent is not dispensed correctly Check R2 disp...

Page 108: ...ited to high calibrator concentration Edit the Linear Range H field to the high calibrator concentration as stated in the calibrator value sheet Poor precision or erroneous results Probable Cause s Corrective Action s R2 reagent arm is out of alignment Adjust the R2 reagent arm Refer to Reagent Arm Adjustment in the Hardware section of this guide R2 reagent is not dispensed correctly Check R2 disp...

Page 109: ...in the updated assay parameter file from the Limit of Detection LOD value of 2 8 U L to the Limit of Quantitation LOQ value of 7 8 U L The LOQ value is rounded up to the number of decimal places defined in the Decimal Places field and results with a value 8 U L are flagged with a LL Result Error Code NOTE LOQ was chosen as the lower limit because it represents the lowest limit at which quantitativ...

Page 110: ...ted Compound SYVA Package Insert µg mL Acetaminophen 1 000 N Acetylprocainamide NAPA 400 Acetylsalicylic acid 1 000 Alpha acetyl N N dinormethadol dinor LAAM 25 l Alpha acetylmethodol LAAM 25 Amitriptyline 1 000 Buprenorphine 100 Caffeine 1 000 Cimetidine 1 000 Clomipramine 2 5 Clonidine 1 000 Codeine 500 Cotinine 100 Cyclobenzaprine 28 Desipramine 800 Diphenhydramine 1 000 Doxepin 10 2 Ethylidene...

Page 111: ...er Distribution Assays Reagents AEROSET System Troubleshooting Guide 111 94816 107 November 2004 Nortriptyline 750 Promethazine 1 000 Ranitidine 900 Scopolamine 500 Tramadol 100 Tyramine 100 Zidovudine AZT 2 mg mL Zolpidem 100 Compound SYVA Package Insert µg mL ...

Page 112: ...ng mL lormetazepam Multi DOA Cutoff calibrator when tested at the concentration listed Compound Concentration Calculated ng mL SYVA Package Insert ng mL 7 aminoflunitrazepam 341 295 Compound SYVA Package Insert µg mL Tested at 150 ng mL Cutoff Acetaminophen 1 000 N Acetylprocainamide NAPA 400 Acetylsalicylic acid 1 000 Alpha acetyl N N dinormethadol dinor LAAM 25 l Alpha acetylmethodol LAAM 25 Ami...

Page 113: ...4 Fluoxetine 500 Glutethimide 500 Ketamine 100 Ketorolac tromethamine 1 000 Lysergic acid diethylamide LSD 10 ng mL Meperidine 1 000 Nortriptyline 750 Phenytoin 1 000 Promethazine 1 000 Ranitidine 900 Scopolamine 500 Thioridazine 100 Tramadol 100 Tyramine 100 Zidovudine AZT 2 mg mL Zolpidem 100 Compound SYVA Package Insert µg mL Tested at 150 ng mL Cutoff ...

Page 114: ...94816 107 November 2004 Calcium Observed Problem LOD LOQ claim not duplicated by customer Probable Cause s Corrective Action s Reagent cross contamination NOTE Creatinine contaminates Calcium at very low levels even with SmartWash configured The contamination is not clinically significant Run Calcium in batch mode for LOD LOQ testing ...

Page 115: ...ncentration listed Compound SYVA Package Insert µg mL Acetaminophen 1 000 N Acetylprocainamide NAPA 400 Alpha acetyl N N dinormethadol dinor LAAM 25 l Alpha acetylmethodol LAAM 25 Buprenorphine 100 Caffeine 1 000 Cimetidine 1 000 Clomipramine 2 5 Clonidine 1 000 Codeine 500 Cotinine 100 Cyclobenzaprine 28 Desipramine 800 Diphenhydramine 1 000 Doxepin 10 2 Ethylidene 1 5 dimethyl 3 3 diphenylpyrrol...

Page 116: ...mple cups should be filled with 600 µL of calibrator control or specimen to minimize the surface to volume ratio Do not use disposable polyethylene transfer pipettes to dispense calibrators controls or specimens Do not redispense solutions from a pipette back into a calibrator control or specimen container includes redispensing after wetting a pipette tip Immerse the pipette tips below the surface...

Page 117: ...pound SYVA Package Insert µg mL Tested at 150 ng mL Cutoff N Acetylprocainamide NAPA 400 Alpha acetyl N N dinormethadol dinor LAAM 25 l Alpha acetylmethodol LAAM 25 Buprenorphine 100 Caffeine 1 000 Cimetidine 1 000 Clomipramine 2 5 Clonidine 1 000 Codeine 500 Cotinine 100 Cyclobenzaprine 28 Desipramine 800 Diphenhydramine 1 000 Doxepin 10 2 Ethylidene 1 5 dimethyl 3 3 diphenylpyrrolidine EDDP 1 00...

Page 118: ...tomer Distribution 118 AEROSET System Troubleshooting Guide 94816 107 November 2004 Promethazine 1 000 Ranitidine 900 Scopolamine 500 Thioridazine 100 Tramadol 100 Tyramine 100 Zidovudine AZT 2 mg mL Zolpidem 100 Compound SYVA Package Insert µg mL Tested at 150 ng mL Cutoff ...

Page 119: ...Probable Cause s Corrective Action s R2 reagent arm is out of alignment Adjust the R2 reagent arm Refer to Reagent Arm Adjustment in the Hardware section of this guide R2 reagent is not dispensed correctly Check R2 dispense components sample or reagent probe syringes wash mixer tubing Check the reagent cartridge for bubbles or foam If present remove with an applicator stick use a new applicator st...

Page 120: ...Probable Cause s Corrective Action s R2 reagent arm is out of alignment Adjust the R2 reagent arm Refer to Reagent Arm Adjustment in the Hardware section of this guide R2 reagent is not dispensed correctly Check R2 dispense components sample or reagent probe syringes wash mixer tubing Check the reagent cartridge for bubbles or foam If present remove with an applicator stick use a new applicator st...

Page 121: ...mg dL in the CRP package insert The insert also states that a study was performed on the AEROSET and ARCHITECT c8000 Systems which resulted in an LOQ of 0 25 mg dL Where did the LOQ claim of 0 50 mg dL originate The LOQ study yielded representative data of 0 25 mg dL worst case result observed The claim of 0 50 mg dL is the Product Requirement minimum acceptable performance which was determined be...

Page 122: ...s not address this issue The customer should check QC performance Freeze thaw studies by the OEM supplier support acceptable performance with frozen material Will customers have an issue if there are not enough Abbott assay users when results from a proficiency survey are compared to other manufacturers CRP assays OPEN QUESTION Under evaluation We do not have data for this However CAP Proficiency ...

Page 123: ...recision studies for the AEROSET and c 8000 Systems were done at different times with different lots of control material The lots are referenced as Lots A and B in the package insert to note this difference Does the milky composition of the CRP R2 reagent have any impact on instrument dispense components No impact was observed over several years of internal product evaluation Did the CRP assay cau...

Page 124: ...nd performance diminishes should we assume that results will increase for this assay Logically less lamp intensity would translate as additional turbidity and therefore higher concentration Were any study data generated with a diminished lamp A specific study has not been performed to evaluate diminished lamp intensity Frequently Asked Questions FAQ Continued Question Answer ...

Page 125: ...sult can be auto diluted 1 2 or 1 10 using the dilution protocols defined for the CK assay Digoxin MULTIGENT Spironolactone Canrenone Interference Results A case report by Steimer et al has shown that a negative bias in the determination of digoxin results may be observed when the aldosterone inhibitor spironolactone or canrenone is present in serum A sample containing 2 0 ng mL of digoxin was spi...

Page 126: ...00 0 0 0 0 Cortisol hydrocortisone 10 000 0 0 0 0 Cortisone 10 000 0 0 0 0 Dehydroisoandrosterone 10 000 0 0 0 0 D Digitoxose 10 000 0 0 0 0 Estriol 10 000 0 0 0 0 Furosemide 50 000 0 0 0 0 Gitoxin 150 0 7 0 5 Hydrochlorothiazide 100 000 0 0 0 0 11α Hydroxyprogesterone 10 000 0 1 0 001 17α Hydroxyprogesterone 10 000 0 0 0 0 Lidocaine HCl 100 000 0 0 0 0 Ouabain octahydrate 150 2 8 1 9 Phenytoin 10...

Page 127: ... lipemia The disagreement between methods may be due to cross reactivity and interference differences Which controls are recommended Which controls have AEROSET assay values Bio Rad Liquichek TDM control has been used successfully with this method although system specific assay values are not provided in the package insert Onboard stability and 20 day precision testing were done with this product ...

Page 128: ...orage and Stability Do not refreeze calibrator The calibrator should not be frozen at 20 C The calibrator concentration changes with each lot number and is listed on the label The calibrator is reconstituted with 1 mL DI water allowed to stand for 5 minutes and swirled until dissolved Due to the low volume of the calibrator 1 mL a 1 mL Class A volumetric pipette should be used Do not shake the cal...

Page 129: ...ated by diluting the high and low level verifiers Refer to the following table 3 Graph the admixtures using 40 as the theoretical value The 40 dilution is considered truth to calculate the remaining admixture s theoretical values a Calculate the mean value of the replicates for each dilution b Calculate the theoretical value of each sample using the value determined for the 40 sample c Plot the re...

Page 130: ...ooting Guide 94816 107 November 2004 g Document findings Sample Mean Result Theoretical Result Recovery 0 0 5 0 N A 20 175 174 40 Mean Result 0 5 101 40 347 347 100 60 80 694 40 Mean Result 1 5 102 80 704 694 40 Mean Result 2 0 101 100 886 868 40 Mean Result 2 5 102 The reportable range has been verified up to 868 mg dL ...

Page 131: ...nst the peer group for LDL Comparison of the homogeneous LDL to ultracentrifugation should be performed using fresh serum samples The doctor is questioning the LDL result high or low Was the test repeated on the original serum or plasma sample Are other lipid results available Is the triglyceride level greater than 1 293 mg dL Sample integrity verify the serum plasma sample was stored at 2 to 8 C ...

Page 132: ...used Levels tested exceeded toxic concentrations Therefore cross reactivity is not considered clinically significant with the exception of n propanol which showed a cross reactivity of approximately 10 in the Ethanol assay GGT Observed Problem Imprecision Probable Cause s Corrective Action s R2 reagent probe is not centered over the cuvette If R2 reagent is dispensed down the side of the cuvette c...

Page 133: ...robable Cause s Corrective Action s R2 reagent arm is out of alignment Adjust the R2 reagent arm Refer to Reagent Arm Adjustment in the Hardware section of this guide R2 reagent is not dispensed correctly Check R2 dispense components sample or reagent probe syringes wash mixer tubing Check the reagent cartridge for bubbles or foam If present remove with an applicator stick use a new applicator sti...

Page 134: ...tional to absorbance change High absorbance change low HbA1c concentration low absorbance change high HbA1c concentration HbA1c Sample Anti HbA1c Antibody Microparticle Complex Reagent 1 HbA1c Antibody Microparticle Complex lower rate of agglutination increased absorbance rate Remaining Unbound Anti HbA1c Antibody Microparticle Complex Reagent 1 HbA1c Hapten Reagent 2 HbA1c Antibody Microparticle ...

Page 135: ...positive displacement micropipette withdraw exactly 10 µL of the well mixed whole blood patient specimen or control 3 Insert the pipette into the microcentrifuge tube containing the Hemoglobin Denaturant allowing the tip of the pipette to barely make contact with the surface of the denaturant Dispense the specimen 1 41 dilution 4 Withdraw and redispense the mixture two times keeping the tip of the...

Page 136: ...ther values were prepared from these standards to yield the midpoint standards An additional standard was created to test the very low end of the curve Each midpoint sample was tested in triplicate results are listed below The spline method of calibration matches the theoretical calculation value at the midpoints of the curve Theoretical g dL Recovered g dL Variation Variation g dL 0 00 0 00 0 0 0...

Page 137: ...room temperature 22 C and 4 C denaturant solutions Sample Mixing Vortex Mixing vs Pipet Mixing A study was performed to evaluate effects of vortex mixing and pipet mixing on sample results Procedures to perform this study are included below Vortex Mix 1 400 µL denaturant was added to plastic tubes using the same tip for three tubes 2 Blood sample was pipetted by rinsing the tip once with blood 3 T...

Page 138: ...outside with precautions taken to not wick any sample 4 Blood was dispensed into denaturant and the tip was rinsed two times 5 The pipet tip used to dispense denaturant was used to mix the treated sample by pipetting and dispensing the sample five times The following data were observed There is no difference in the final HbA1c result based on mixing method Vortex Mix Pipet Mix Prep 1 Rep 1 8 4 8 2...

Page 139: ...dardization Program NGSP website it lists effects of frequently encountered hemoglobin variants and derivatives on HbA1c GHB measurement A list of references can be found on the website http web missouri edu diabetes ngsp html All of these methods with the exception of Beckman Diatrac and Helena Glyco Tek were NGSP certified as of March 2002 Method Interference Yes No HbC Trait HbS Trait HbE Trait...

Page 140: ...oting Guide 94816 107 November 2004 Provalis Glycosal Bio Rad MicroMat Yes No Roche Cobas Integra Yes Yes Roche Tina quant II No No No No 울 30 HbF No Roche Unimate Yes Yes No Tosoh A1c 2 2 Plus No No Yes Yes No Conflicting data in literature Method Interference Yes No HbC Trait HbS Trait HbE Trait Elevated HbF Carbamyl Hb ...

Page 141: ...n rates Is this normal This is normal The indirect assay method provides a curve in which the signal is inversely proportional to concentration i e low sample values produce the highest rates The zero calibrator rate highest rate is used as a blank and is subtracted from the rates of all the other calibrators causing them to be negative How does this assay perform with specific hemoglobin variants...

Page 142: ... because there are fewer binding sites available for the agglutinator This results in a lower absorbance change over time Does Abbott have microcentrifuge tubes Abbott TDx centrifuge tubes LN 9527 40 can be ordered There are 100 tubes per box There is no sample probe SmartWash in assay configuration Was hemolysate build up on the sample probe an issue during assay testing Studies were run on assay...

Page 143: ...nerated When the Error Log Message 351 ICT Reference Solution Cup Not Filling or 352 ICT Reference Solution Not Aspirated is generated the ICT result is masked but the L and H result flags display Resolution There is no corrective action to mask the L and H flag Refer to Error Log Messages Supplemental Information in Section 10 Troubleshooting and Diagnostics of the AEROSET System Operations Manua...

Page 144: ...ation as stated in the calibrator value sheet Poor precision or erroneous results Probable Cause s Corrective Action s R2 reagent arm is out of alignment Adjust the R2 reagent arm Refer to Reagent Arm Adjustment in the Hardware section of this guide R2 reagent is not dispensed correctly Check R2 dispense components sample or reagent probe syringes wash mixer tubing Check the reagent cartridge for ...

Page 145: ...s Probable Cause s Corrective Action s R2 reagent arm is out of alignment Adjust the R2 reagent arm Refer to Reagent Arm Adjustment in the Hardware section of this guide R2 reagent is not dispensed correctly Check R2 dispense components sample or reagent probe syringes wash mixer tubing Check the reagent cartridge for bubbles or foam If present remove with an applicator stick use a new applicator ...

Page 146: ...ed in the calibrator value sheet Poor precision or erroneous results Probable Cause s Corrective Action s Issues with the source lamp Check the lamp Normal lamp function flat line between reads 2 and 16 and a smooth line bending from vertical to horizontal between reads 17 and 33 Lamp degeneration progress curve not smooth exhibits an erratic sawtooth appearance R2 reagent arm is out of alignment ...

Page 147: ...ROSET System Troubleshooting Guide 147 94816 107 November 2004 Reagent container bar code label not read Probable Cause s Corrective Action s Bar code label not positioned correctly Check positioning of the R1 and R2 reagent bottles verify the bar code label is facing the center of the carousel ...

Page 148: ...iron concentration reduced when measured by method on Kodak Ektachem systems In addition the Vitros uses ascorbic acid as a reducing agent Ascorbic acid is unique in its property not only to reduce but also chelate iron Iron methodologies containing ascorbic acid are prone to over recovery of serum iron liberated from non transferrin sources In one study ascorbic acid significantly and selectively...

Page 149: ...eters In the Abbott Clinical Chemistry Iron Magnesium calibrator package insert calibrator values for the Magnesium assay are provided in mEq L and mmol L units The calibrator vial lists Magnesium units in mEq L only due to limited area available on the vial label Package inserts will be revised at a later date to include values for mg dL these values are listed in the following table When convert...

Page 150: ...field from mEq L to mg dL 4 Edit control mean values on the CALIBRATOR CONTROL screen 5 Verify all edits are saved 6 Calibrate the Magnesium and or Magnesium Urine assays as appropriate 7 Run two levels of controls to verify the calibration Parameters Requiring Edits Serum Plasma Values in mg dL Urine Values in mg dL L Reference 2 1 User defined value 1 215 rounded to one significant digit Referen...

Page 151: ...tration listed Compound SYVA Package Insert µg mL N Acetylprocainamide NAPA 400 l Alpha methadol 2 Buprenorphine 100 Caffeine 1 000 Cimetidine 1 000 Clomipramine 2 5 Clonidine 1 000 Cotinine 100 Cyclobenzaprine 28 Desipramine 800 Diphenhydramine 500 Doxepin 10 2 Ethylidene 1 5 dimethyl 3 3 diphenylpyrrolidine EDDP 1 000 Fluoxetine 500 Glutethimide 500 Ibuprofen 1 000 Ketamine 100 Ketorolac trometh...

Page 152: ...ior to testing if not reduced values could be observed Frequently Asked Questions FAQ Question Response Can I use another vendor s controls or is use of MULTIGENT Microalbumin controls required Bovine or other sourced control material e g Bio Rad controls do not work with the MULTIGENT Microalbumin assay The control must be a human sourced control Use MULTIGENT Microalbumin controls LN 2K98 10 If ...

Page 153: ...pound SYVA Package Insert µg mL Acetaminophen 1 000 N Acetylprocainamide NAPA 400 Acetylsalicylic acid 1 000 Alpha acetyl N N dinormethadol dinor LAAM 25 l Alpha acetylmethodol LAAM 25 Amitriptyline 500 Buprenorphine 100 Caffeine 1 000 Cimetidine 1 000 Clomipramine 2 5 Clonidine 1 000 Cotinine 100 Cyclobenzaprine 28 Desipramine 800 Diphenhydramine 1 000 Doxepin 10 2 Ethylidene 1 5 dimethyl 3 3 dip...

Page 154: ...in or levofloxacin Levaquin non opiates may produce positive results with this assay A positive result from an individual taking ofloxacin or levofloxacin should be interpreted with caution and confirmed by another method Phenytoin 1 000 Promethazine 143 Ranitidine 900 Scopolamine 500 Thioridazine 100 Tramadol 100 Tyramine 100 Zidovudine AZT 2 mg mL Zolpidem 100 Compound SYVA Package Insert µg mL ...

Page 155: ...ed Compound SYVA Package Insert µg mL Acetaminophen 1 000 N Acetylprocainamide NAPA 400 Acetylsalicylic acid 1 000 Alpha acetyl N N dinormethadol dinor LAAM 25 l Alpha acetylmethodol LAAM 25 Amitriptyline 1 000 Buprenorphine 100 Caffeine 1 000 Cimetidine 1 000 Clomipramine 2 5 Clonidine 1 000 Cotinine 100 Cyclobenzaprine 28 Desipramine 800 Diphenhydramine 1 000 Doxepin 10 2 Ethylidene 1 5 dimethyl...

Page 156: ...n or levofloxacin Levaquin non opiates may produce positive results with this assay A positive result from an individual taking ofloxacin or levofloxacin should be interpreted with caution and confirmed by another method Phenytoin 1 000 Promethazine 1 000 Ranitidine 900 Scopolamine 500 Thioridazine 100 Tramadol 100 Tyramine 100 Zidovudine AZT 2 mg mL Zolpidem 100 Compound SYVA Package Insert µg mL...

Page 157: ...ion listed Compound SYVA Package Insert µg mL Acetaminophen 1 000 N Acetylprocainamide NAPA 400 Acetylsalicylic acid 1 000 l Alpha acetylmethodol LAAM 25 Buprenorphine 100 Caffeine 1 000 Cimetidine 1 000 Clomipramine 2 5 Clonidine 1 000 Codeine 500 Cotinine 100 Cyclobenzaprine 28 Desipramine 800 Diphenhydramine 1 000 Doxepin 10 2 Ethylidene 1 5 dimethyl 3 3 diphenylpyrrolidine EDDP 1 000 Fluoxetin...

Page 158: ...NFIDENTIAL MATERIAL Assays Reagents Not for Customer Distribution 158 AEROSET System Troubleshooting Guide 94816 107 November 2004 Tramadol 100 Tyramine 100 Zidovudine AZT 2 mg mL Zolpidem 100 Compound SYVA Package Insert µg mL ...

Page 159: ...16 and a smooth line bending from vertical to horizontal between reads 17 and 33 Lamp degeneration progress curve not smooth exhibits an erratic sawtooth appearance R2 reagent arm is out of alignment Adjust the R2 reagent arm Refer to Reagent Arm Adjustment in the Hardware section of this guide R2 reagent is not dispensed correctly Check R2 dispense components sample or reagent probe syringes wash...

Page 160: ...at the concentration listed Compound SYVA Package Insert µg mL Acetaminophen 1 000 N Acetylprocainamide NAPA 400 Acetylsalicylic acid 1 000 Alpha acetyl N N dinormethadol dinor LAAM 25 l Alpha acetylmethodol LAAM 25 Buprenorphine 100 Cimetidine 1 000 Clomipramine 2 5 Clonidine 1 000 Cotinine 100 Diphenhydramine 1 000 Doxepin 10 Fluoxetine 500 Glutethimide 500 Ibuprofen 1 000 Ketamine 100 Ketorolac...

Page 161: ...TION CONFIDENTIAL MATERIAL Not for Customer Distribution Assays Reagents AEROSET System Troubleshooting Guide 161 94816 107 November 2004 Tyramine 100 Zidovudine AZT 2 mg mL Zolpidem 100 Compound SYVA Package Insert µg mL ...

Page 162: ...eins Version 1 0 NOTE At the end of control shelf life means may shift and control ranges may need to be reestablished Bio Rad Liquichek RF Control Level 1 varies in concentration Recommendation Do not use Level 1 if 15 IU mL Standard Material Recovery Recovery accuracy results of the standard material are summarized in the following table Assay Standard Material N Units Expected Value Recovered M...

Page 163: ...nappropriately required reevaluation after control ranges were established Based on our experience however the need to reevaluate control ranges should be infrequent The RF R2 reagent contains latex microparticles Is inversion of R2 reagent required before every run to ensure the particles do not settle Inversion is not required before running the test The latex microparticles are very small and r...

Page 164: ...agent kits are inadvertently frozen during delivery The package insert does not address this issue The customer should check QC performance Freeze thaw studies by the OEM supplier support acceptable performance with frozen material Will customers have an issue if there are not enough Abbott assay users when results from a proficiency survey are compared to other manufacturers RF assays CAP surveys...

Page 165: ...used The frequency of obtaining a Level 1 control with a concentration too small is dependent on Bio Rad manufacturing processes If RF is not inverted before use what errors are observed A specific study has not been performed However if latex particles have settled to the bottom of the reagent cartridge and are not pipetted it is possible that low absorbance values could be observed Is the Hitach...

Page 166: ...l years of internal product evaluation Did the RF assay cause any build up in the high concentration waste pump manifold tubing No impact was observed over several years of internal product evaluation If a reagent kit was not mixed properly before use then discovered after the fact would it be acceptable to mix and run controls to determine whether to continue use The amount of volume used for tes...

Page 167: ...re complex with copper and tartrate in the reaction mixture and form a precipitate The degree of the resulting interference varies greatly with the concentration of dextran and the composition of the biuret reagent The percent interference can range from 3 to 5 at usually encountered dextran levels Although the interference is usually a positive one a negative interference was reported for the bic...

Page 168: ...robable Cause s Corrective Action s R2 reagent arm is out of alignment Adjust the R2 reagent arm Refer to Reagent Arm Adjustment in the Hardware section of this guide R2 reagent is not dispensed correctly Check R2 dispense components sample or reagent probe syringes wash mixer tubing Check the reagent cartridge for bubbles or foam If present remove with an applicator stick use a new applicator sti...

Page 169: ... for interference from human anti mouse antibodies HAMA in the patient sample To test this we obtained a normal human serum pool control and two types of human anti mouse antibodies HAMA type 1 and HAMA type 2 We then spiked them with identical amounts of valproic acid Each sample was assayed in duplicate on the AEROSET System using the MULTIGENT Valproic Acid assay The means of both duplicate HAM...

Page 170: ...d lipemia The disagreement between methods may be due to cross reactivity and interference differences Which controls are recommended Which controls have AEROSET assay values Bio Rad Immunoassay Plus controls have been used successfully with this method although system specific assay values are not provided in the package insert Why am I getting negative calibration rates Is this normal This is no...

Page 171: ...AEROSET System Troubleshooting Guide 171 94816 107 November 2004 Section 10 Software System Troubleshooting Guide Software ...

Page 172: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution 172 AEROSET System Troubleshooting Guide 94816 107 November 2004 NOTES ...

Page 173: ...alidated Black Run Progress Patient Sample Gray STAT Sample Pink Calibrator Green Control Yellow Water Bath Hot Pink OK Green Cold Blue Controls Levey Jennings Graph 2 SD Yellow 1 SD Green 3 SD Red Outside 3 SD Blue Cal Summary Pending Cal expired Pink OK Black Failed Brown START UP SHUTDOWN Bulk solutions low Red Bulk solutions OK Green Reagent Expired empty Pink OK Green Reagent low Brown Reagen...

Page 174: ... v1 02ER000 the folder is named EXTERNAL This change does not impact file names which are user defined and does not impact the export function Exported Files Due to an anomaly associated with the Export function when exported files are imported into a PC spreadsheet csv format certain characters may not appear correctly on the spreadsheet The following are some examples of this anomaly French char...

Page 175: ...Display Area 4 Type dbgmode at the c prompt then press Enter 5 In the drop down list box next to Online select Printer 6 Select OK 7 Type exit at the c prompt to return to the Main Display When the Host communication error Illegal Message Text Error is generated ensure the Host is configured to resend the sample Use the following instructions to disable the Host Interface Trace log 1 Log On with t...

Page 176: ... requires a dilution is aspirated from the sample cup 2 A clotted sample is aspirated and a CLT Result Error Code is generated 3 The sample probe moves to the wash cup to attempt removal of clot 4 The diluted sample cannot be dispensed into a new cuvette and is flagged with a CLT Result Error Code After the clot or clotted sample is removed from the system rerun the diluted sample START is selecte...

Page 177: ...tion s START was selected when the system status was changing from SUSPEND to READY 1 Select STAT in the Action Area of the Main Display The SELECT ASSAYS FOR STAT screen displays 2 Select START to initiate the run Unresolved Host communications error including but not limited to Error Log Message 339 Time Out Order Not Received from SCC Probable Cause s Corrective Action s Communication failure b...

Page 178: ... all assays is reset by the instrument being powered off or when the interval occurs on a different day In this example the system was powered off as part of SHUTDOWN and the interval for the QC was reset QC Rounding For a QC result to be flagged with an L or H Result Flag the mean concentration and SD must be considered A result is rounded to the reporting number of decimals for an assay after co...

Page 179: ...igured in the Decimal Places field on the Base page of the Assay Configuration screen Mean Decimal places value 1 additional decimal place SD Decimal places value 1 additional decimal place CV 2 Decimal places fixed Range Decimal places value Decimal Places Value Base Page of Assay Configuration Screen Decimal Places of Mean Values Decimal Places of SD Values Decimal Places of CV Values Decimal Pl...

Page 180: ... Sequence Aspirates photometric assays using Smart Sampling scheduling Iron is always aspirated last Runs assays as defined in Sample Sequence except Iron Then runs assays in the order of buttons on the ASSAYS screen left to right Iron is last independent of button placement Sample Sequence Not Defined Aspirates using Smart Sampling scheduling ICT assays are run later in the run Iron is always asp...

Page 181: ...n Area of the Main Display RUN OPTIONS SELECT ASSAYS FOR STAT START UP OPTIONS SHUTDOWN OPTIONS ERROR LOG HOST COMMUNICATION Printer Configuration Log On SysCfg Beep OFF SmplSeq Sampling ONLINE CONFIGURATION ResetErr System SCC Rgt Area 2 Rgt Area 1 QC Rule Rxn Area SW Info MAINTENANCE UTILITIES Print STOP REAGENT SCAN RUN OPTIONS SysCfg SmplSeq QC Rule Cancel Save Start ...

Page 182: ... Config Calib Export Datalist Details QC Replace Clear Wizard Export Import FreeText ReCalc Edit Rerun Reaction Graph Accept Calibration Base Outline Add Delete Levey Jennings Graph Cal Details Rerun Rules SmartWash QC Error Status Set 2 Set 1 C C Crsl Abs Data Export Save Export Import Print Set 3 Export Datalist Details Delete R1 D R1 C R1 B R1 A View R2 B R2 A R2 C R2 D Clear All Report Options...

Page 183: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 183 94816 107 November 2004 Screen Navigation Main Display REAGENTS Screen ...

Page 184: ...stomer Distribution 184 AEROSET System Troubleshooting Guide 94816 107 November 2004 REAGENTS Supply Center Segment Screen Reagent Supply Center Segment Details Screen DILUENT Bar Code Scanned Reagent name text is BROWN Manually Configured Reagent name text is BLACK ...

Page 185: ...Y INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 185 94816 107 November 2004 DATABASE Screen Search Dialog Window Patient Demographics Dialog Window ...

Page 186: ...ARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution 186 AEROSET System Troubleshooting Guide 94816 107 November 2004 Print Options Dialog Window Order List Loadlist Order Samples Screen ...

Page 187: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 187 94816 107 November 2004 PAGE SETUP Screen Form 1 Form 1 Report ...

Page 188: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution 188 AEROSET System Troubleshooting Guide 94816 107 November 2004 PAGE SETUP Screen Form 2 Define Free Text Screen ...

Page 189: ...3 10 Instrument 0001 Address 1 Address 2 Address 3 Address 4 Address 5 Sample ID Age Name Nelson Harry Sex Patient ID Doctor Carrier Pos 1 4 Date Time Run 5 21 98 11 32 Comment ASSAY LOW HIGH RESULT REFERENCE RANGES Na S L 135 mmol L 136 0 145 0 CO2 25 mEq L 22 0 29 0 Urea 12 mg dL 7 0 18 0 ALT 12 U L 10 0 35 0 Crea H 1 4 mg dL 0 7 1 3 Ca H 12 3 mg dL 8 4 10 2 Phos L 2 6 mg dL 2 7 4 5 TBil 0 8 mg ...

Page 190: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution 190 AEROSET System Troubleshooting Guide 94816 107 November 2004 RESULT Screen RESULT Screen Viewing Rerun Result ...

Page 191: ...TARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 191 94816 107 November 2004 Reaction Graph Screen Error Code Reaction Graph Screen Rate Assay ...

Page 192: ...FIDENTIAL MATERIAL Software Not for Customer Distribution 192 AEROSET System Troubleshooting Guide 94816 107 November 2004 Reaction Graph Screen End point Assay Absorbance Data Screen DATABASE Screen Accept Results Dialog Window ...

Page 193: ...PRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 193 94816 107 November 2004 CALIBRATOR CONTROL Screen CALIBRATOR CONTROL Screen Set 1 ...

Page 194: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution 194 AEROSET System Troubleshooting Guide 94816 107 November 2004 Position Dialog Window CALIBRATION SUMMARY Screen ...

Page 195: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 195 94816 107 November 2004 Calibration Details Screen QC SUMMARY Screen ...

Page 196: ...PRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution 196 AEROSET System Troubleshooting Guide 94816 107 November 2004 Levey Jennings Graph Screen Print Options QC Dialog Window ...

Page 197: ...Y INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 197 94816 107 November 2004 Levey Jennings Graph Report QC Details Dialog Window QC Data List Screen ...

Page 198: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution 198 AEROSET System Troubleshooting Guide 94816 107 November 2004 ASSAYS Screen ASSAY STATUS Screen ...

Page 199: ...ION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 199 94816 107 November 2004 Assay Configuration Screen Outline Page Assay Configuration Screen Base Page End point Assay ...

Page 200: ...TIAL MATERIAL Software Not for Customer Distribution 200 AEROSET System Troubleshooting Guide 94816 107 November 2004 Assay Configuration Screen Base Page Rate Assay Assay Configuration Screen Calibration Page Linear Calibration Mode ...

Page 201: ...MATION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 201 94816 107 November 2004 Assay Configuration Screen SmartWash Page Assay Configuration Screen Rerun Rules Page ...

Page 202: ... Not for Customer Distribution 202 AEROSET System Troubleshooting Guide 94816 107 November 2004 RUN OPTIONS Screen SYSTEM CONFIGURATION Screen NOTE The Sample Barcodes Reagent Barcodes External Robotics and ICT fields can only be edited using guest Log On ...

Page 203: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 203 94816 107 November 2004 SELECT ASSAYS FOR STAT Screen Pause Function ...

Page 204: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution 204 AEROSET System Troubleshooting Guide 94816 107 November 2004 Unpause Function START UP OPTIONS Screen ...

Page 205: ...FORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 205 94816 107 November 2004 SHUTDOWN OPTIONS Screen ERROR LOG Screen Level 1 Red Level 2 Pink Level 3 Yellow ...

Page 206: ...MATERIAL Software Not for Customer Distribution 206 AEROSET System Troubleshooting Guide 94816 107 November 2004 MAINTENANCE UTILITIES Screen System Page NOTE Zero Set is only visible with guest Log On MAINTENANCE UTILITIES Screen SCC Page ...

Page 207: ...TIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 207 94816 107 November 2004 MAINTENANCE UTILITIES Screen Sampling Page NOTE Step Edit is visible only with guest Log On Pressure Monitor Screen ...

Page 208: ...TION CONFIDENTIAL MATERIAL Software Not for Customer Distribution 208 AEROSET System Troubleshooting Guide 94816 107 November 2004 MAINTENANCE UTILITIES Screen Rgt Area 1 Page MAINTENANCE UTILITIES Screen Rgt Area 2 Page ...

Page 209: ...ETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution Software AEROSET System Troubleshooting Guide 209 94816 107 November 2004 MAINTENANCE UTILITIES Screen Rxn Area Page Cuvette Blank Screen ...

Page 210: ...NFIDENTIAL MATERIAL Software Not for Customer Distribution 210 AEROSET System Troubleshooting Guide 94816 107 November 2004 Cuvette Integrity Check Screen MAINTENANCE UTILITIES Screen SW Info Page Printer A Configuration Window ...

Page 211: ...ystem Troubleshooting Guide 211 94816 107 November 2004 ONLINE HOST CONFIGURATION Dialog Window Run Progress Area Log On Screen User Alert Dialog Window With Optional Clot Detection and Sample Carryover Reduction Installed Without Optional Clot Detection and Sample Carryover Reduction Installed ...

Page 212: ...s listed below after upgrade to software v1 02ER000 will have a FAC Limit default setting of 0 and must be edited to 10 The FAC Limit was defined as 10 in all versions of AEROSET software prior to v1 02ER000 but this was not an editable field This value was used in validation testing for all currently released Abbott assays and was applied to any non Abbott assays configured on the system prior to...

Page 213: ...ftware The Unit Configuration and automatic Startup Shutdown Setting screens should only be accessed by Abbott personnel Perform the following steps to access these screens 1 Log On with the extra or guest level user code and password 2 Perform the steps below to access the Unit Configuration or automatic Startup Shutdown Setting screens a Press Alt Print Screen on the keyboard at the same time Th...

Page 214: ... Unit Configuration screen only select OK on the Save Parameters confirmation dialog window to return to the c prompt 6 Type exit then press Enter 7 Select the Exit icon in the Action Area of the Main Display to Log Off the system 8 On the Log On screen type bye in the User Code field 9 Perform the Power OFF Procedure wait 15 seconds then Power ON the system ...

Page 215: ...wn below Also included is a table that describes fields on the Unit Configuration screen which can be affected if the System Configuration Software Disk v3 0 is loaded after upgrade to software v1 02ER000 Figure 7 Unit Configuration Screen Default View Figure 8 Unit Configuration Default Screen Default View Page 2 Software Version 1 02ER000 NOTE For software v1 03ER000 refer to the following page ...

Page 216: ...rom the default settings Unit Configuration Screen Default View Page 2 Software Version 1 03ER000 Figure 9 Unit Configuration Default Screen Default View Page 2 Software Version 1 03ER000 NOTE The New Sample Wash Cup option should only be selected if the optional hardware upgrade was installed Review the Log On screen to determine if this hardware was installed Unit Configuration Screen Field Defa...

Page 217: ...ffected if the System Configuration Software Disk v3 0 is loaded after upgrade to software v1 02ER000 Figure 10 Startup Shutdown Startup 1 Settings Screen Default View None of the Automatic START UP Options are customer defined Each of these settings should match the defaults listed in this table Automatic START UP Options Option Startup 1 Startup 2 Startup 3 Change Bath water X X X Wash Cuvettes ...

Page 218: ... Setting Screen Default View Automatic SHUTDOWN Options Option Shutdown 1 Shutdown 2 Shutdown 3 Change Bath water X X X Wash Cuvettes X X X Fill with Dtg Wash Probes by Water Alk Wash Acid Wash Alk Acid Alk Water Alk Wash ISE by ICAL IRef EW I Clean EW ICAL EW ICAL Change MCC Drain Fill IRef Cup X Clear Database Cal QC All Results All Records Cal QC QC Clo All Res QC Clo All Rec QC Clo ...

Page 219: ...hanges daily so the customer does not have permanent or ongoing access The new user code is guest and the password is the same daily number used for IMx and AxSYM 1 0507 21 0729 2 0128 22 0321 3 0908 23 1128 4 0816 24 0701 5 1006 25 0603 6 0222 26 0808 7 0524 27 0418 8 1026 28 0922 9 0130 29 1102 10 0817 30 0221 11 1107 31 0702 12 0513 32 0220 13 0616 33 1207 14 0202 34 0315 15 1016 35 0405 16 072...

Page 220: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution 220 AEROSET System Troubleshooting Guide 94816 107 November 2004 NOTES ...

Page 221: ...AEROSET System Troubleshooting Guide 221 94816 107 November 2004 Section 10 Hardware Hardware ...

Page 222: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Hardware Not for Customer Distribution 222 AEROSET System Troubleshooting Guide 94816 107 November 2004 NOTES ...

Page 223: ...CPU Used with the AEROSET System The following table describes units used with the AEROSET System Figure 11 AEROSET CPU Rear View 133 233 MHz CPU Memory RAM ETM10 AD Pentium 133 MHz 16 MB Pentium MMX 233 MHz 64 MB Celeron 566 MHz 256 MB Keyboard Port Printer Port 125649 Host Port Power Receptacle Monitor Port Touchscreen GPIB Port Alignment Pin Port ...

Page 224: ...RIAL Hardware Not for Customer Distribution 224 AEROSET System Troubleshooting Guide 94816 107 November 2004 Figure 12 AEROSET CPU Rear View 566 MHz Power Receptacle Printer Port Monitor Port Touchscreen Port GPIB Port Keyboard Port Host Port ...

Page 225: ... The AEROSET cuvette warranty is one year post installation Cuvette Identification New cuvettes type H are shipped dry however cuvettes have been shipped dry since cuvette type G That remains a valid way to identify good cuvettes but type G cuvettes are also acceptable The only exact way to identify cuvettes is on the cuvette segment itself The letter designation is located on the underside of the...

Page 226: ...e ICT module verify it is within the stated usage period The ICT module expiration date is on the label of the ICT module box The expiration date can also be calculated by adding seven months to the date of manufacture coded in the ICT module lot number The customer should receive the ICT module a minimum of 90 days before the expiration date Noise Specifications When the instrument is running con...

Page 227: ...rred A Line 343 Sample Aspiration Error Occurred B Line 344 Unable to Remove Sample Probe Obstruction A Line 345 Unable to Remove Sample Probe Obstruction B Line NOTE Refer to the following illustrations for details Probable Cause s Corrective Action s Sample probe is obstructed or damaged Clean or replace sample probe Sample arm tubing is crimped Replace the sample arm tubing Pressure sensor tubi...

Page 228: ...or Log Message X X equals 1 through 11 Probable Cause s Corrective Action s GPIB cable is loose or defective CPU printed circuit board is defective Flash memory data are corrupt SCC previously configured in Demo mode and software reloaded 1 Reseat the GPIB cable 2 Reset error in the Error Log 3 Cycle power to the analyzer 4 Flash memory 5 Reconfigure SCC to Demo mode Cable to PCB Tubing to Probe S...

Page 229: ...em DI water source is not functioning 1 Check the DI water system 2 Perform the Flush Water Lines option of the START UP Procedure Refer to Section 9 Service and Maintenance of the AEROSET System Operations Manual 3 Check for water delivery to the Reagent Supply Centers Bellows pump failure valve failure Contact your Abbott Representative Refrigerator condensation pan contains bluish water Probabl...

Page 230: ...r 2004 Serial Numbers Interpretation of AEROSET serial numbers A AEROSET 3 2003 2 2002 1 2001 0 2000 9 1999 8 1998 7 1997 51 January 52 February 53 March 54 April 55 May 56 June 57 July 58 August 59 September 60 October 61 November 62 December 2 Space holder 001 Sequence Number For example A0542236 means AEROSET April 2000 Sequence Number 236 ...

Page 231: ... C pH 5 0 to 7 0 5 0 to 7 0 Total Organic Carbon Not greater than 500 ppb Not greater than 500 ppb Total Bioburden Does not exceed 10 000 CFU 100 mL Does not exceed 10 000 CFU 100 mL Endotoxin N A Not more than 0 25 Endotoxin Unit per mL Coliform Level Zero per 100 mL Zero per 100 mL Refer to USP 24 NF19 Monograph 645 Water Conductivity if conductivity meter is not temperature compensated or condu...

Page 232: ... if additional troubleshooting is necessary Materials Required None Procedure 1 Ensure the system status is READY 2 Remove one cuvette segment 3 Select the Maintenance Utilities icon in the Action Area of the Main Display The MAINTENANCE UTILITIES screen displays 4 Select the Rxn Area tab The Rxn Area page displays Figure 16 MAINTENANCE UTILITIES Screen Rxn Area Page 5 Using the Rxn Crsl buttons r...

Page 233: ... Gain value is 4 0 replace the lamp Refer to Source Lamp Replacement in Section 9 Service and Maintenance of the AEROSET System Operations Manual After lamp replacement recheck the Gain and A D values verify all Gain values are 울 2 6 and A D readings are 35 000 If not resolved contact your Abbott Representative 9 Print the screen for reference Select OK The Rxn Area page of the MAINTENANCE UTILITI...

Page 234: ... Materials Required Empty reagent cartridge large size R1A Probe Horizontal Adjustment NOTE Any robotic position can be adjusted using the Adj Adjust button clockwise or counterclockwise after moving the robotic arm to that particular position 1 Select the Maintenance Utilities icon in the Action Area of the Main Display The MAINTENANCE UTILITIES screen displays 2 Select the Rgt Area 1 tab The Rgt...

Page 235: ...ty cartridge in the R1A adjustment position 5 Select Rgt Arm A Horz Rgt Adj CAUTION The R1A reagent probe moves over the Reagent Carousel 6 Verify the reagent probe is centered over the cartridge in position A1 7 8 Select Adjust on the right side of the screen If Then Reagent probe is not centered over the cartridge Proceed to step 8 Reagent probe is centered over the cartridge Proceed to step 16 ...

Page 236: ...wn Adj Verify the probe is centered in the cartridge 13 Select Rgt Arm A Vert Home Up Adj NOTE Proceed to step 14 if additional adjustment is needed 14 NOTE If unable to center the probe front to back proceed to Reagent Carousel Alignment 15 When the probe is centered select OK to save the position 16 Select OK on the MAINTENANCE UTILITIES screen then select OK on the Home All Robotics dialog wind...

Page 237: ...an empty reagent cartridge in position A1 of the Reagent Supply Center 2 Select the Maintenance Utilities icon in the Action Area of the Main Display The MAINTENANCE UTILITIES screen displays 3 Select the Rgt Area 1 tab The Rgt Area 1 page displays 4 Select Rgt Arm A Horz Rgt Adj 5 Select A Line Outer A Adj Figure 19 MAINTENANCE UTILITIES Screen Rgt Area 1 Page NOTE Steps 1 through 5 position the ...

Page 238: ...ockwise as needed to center the probe over the reagent cartridge 9 Select OK to save the position 10 Select Rgt Arm A Vert Down Adj 11 Verify the reagent arm position 12 13 Select Rgt Arm A Vert Home Up Adj 14 Repeat steps 4 through 12 If Then Reagent probe is not aligned over the reagent cartridge Proceed to step 13 Reagent probe is aligned over the reagent cartridge Select OK on the MAINTENANCE ...

Page 239: ...4816 107 November 2004 R1A Probe Cuvette Alignment 1 Select the Maintenance Utilities icon in the Action Area of the Main Display The MAINTENANCE UTILITIES screen displays 2 Select the Rgt Area 1 tab The Rgt Area 1 page displays Figure 20 MAINTENANCE UTILITIES Screen Rgt Area 1 Page 3 Select Rgt Arm A Cuv Adj Rgt Arm A Cuv Adj ...

Page 240: ...shooting Guide 94816 107 November 2004 4 Verify the R1A probe is centered over the A Line cuvette in the Reaction Carousel 5 6 Select Adjust on the right side of the screen If Then R1A probe is not centered over the cuvette Proceed to step 6 R1A probe is centered over the cuvette Proceed to step 9 A Line Cuvette ...

Page 241: ...4 7 Select CW clockwise or CCW counterclockwise as needed to center the probe over the reagent cartridge NOTE If unable to align the reagent probes contact your local Abbott Representative 8 Select OK to save the position 9 Select OK on the MAINTENANCE UTILITIES screen then select OK on the Home All Robotics dialog window Clockwise Counterclockwise ...

Page 242: ...h Cup Alignment 1 Select the Maintenance Utilities icon in the Action Area of the Main Display The MAINTENANCE UTILITIES screen displays 2 Select the Rgt Area 1 tab The Rgt Area 1 page displays Figure 21 MAINTENANCE UTILITIES Screen Rgt Area 1 Page 3 Select Rgt Arm A WCup Adj NOTE The reagent arm may not move if it is centered over the wash cup Rgt Arm A WCup Adj ...

Page 243: ...SET System Troubleshooting Guide 243 94816 107 November 2004 4 Verify the R1A probe is centered over the wash cup 5 6 Select Adjust on the right side of the screen If Then R1A probe is not centered over the wash cup Proceed to step 6 R1A probe is centered over the wash cup Proceed to step 9 ...

Page 244: ...t Arm A Vert Down Adj 10 Verify the R1A probe is centered in the wash cup 11 12 Select Rgt Arm A Vert Home Up Adj 13 Repeat steps 3 through 12 NOTE If the probe fails to align in the wash cup contact your Abbott Representative 14 Select OK on the MAINTENANCE UTILITIES screen then select OK on the Home All Robotics dialog window If Then Reagent probe is not centered in the wash cup Proceed to step ...

Page 245: ...AEROSET System Troubleshooting Guide 245 94816 107 November 2004 Flowcharts Troubleshooting Flowcharts ...

Page 246: ...PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Flowcharts Not for Customer Distribution 246 AEROSET System Troubleshooting Guide 94816 107 November 2004 NOTES ...

Page 247: ...rforming as expected Can performance change be traced to a certain event or date Yes Text for assay on ASSAYS screen green Yes Stop Investigate the following bullet points next page Troubleshoot event or investigate implementation of different lots shipments of reagent or calibrator for date in question Yes No No No Yes No Proceed to QC OOR Flowchart QC OOR Proceed to Illegal Configuration or Cali...

Page 248: ...the issue affects one assay Verify assay parameters with the assay specific package insert Was a different bottle of reagent calibrator or control used and was it handled correctly Was a different lot of calibrator or reagent used Are there any non Abbott assays on the original line If so were carryover studies performed between those assays and the affected assay Move the assay to an alternate li...

Page 249: ...eshooting Guide 249 94816 107 November 2004 2 If issue is only on one line troubleshoot Sample probes for damage obstruction and alignment Reagent probes for damage obstruction and alignment All probe tubing for crimps or leaks Sample reagent and wash solution syringes Mixers Maintenance Probe mixer wash flow ...

Page 250: ...endor Yes Instrument maintenance up to date Yes Carryover studies performed Refer to Vendor Perform carryover studies No No No Perform maintenance recalibrate rerun controls Yes No Yes Refer to Vendor Yes No Patient issue Sample handling correct No Yes Correct repeat Resolved No Stop All calibrator targets entered correctly Yes Calibration concern No No Correct values recalibrate Resolved No No Ye...

Page 251: ...r is black Start Load reagents then perform reagent scan or load diluent configure manually No Yes Yes Cartridge empty or low Move reagent to correct line rescan reagents No Yes Bar code label facing outward Yes Label damaged No Readjust cartridges then perform reagent scan Yes Manually configure reagent No Select tab on REAGENTS screen matching the position reagent present No Access Base page on ...

Page 252: ...brator is defined it must be placed in the specified position 3 If a Use Factor calibration method is specified the assay for the referred calibration curve must be configured 4 If a diluent is defined it must be placed in the specified position 5 Sample Interference Indices photometric assays to be run must be specified and configured 6 Calculation Assays all assays used for the calculation must ...

Page 253: ...lace syringe seal tips O rings Dripping resolved Lamp onboard 2 months Replace lamp Yes Drain fill water bath Yes Cuvette segments loose Yes Wash nozzles dripping or misaligned No No Yes Cuvette overfill Dryer tips discolored No Configure SmartWashes Tighten Stylet nozzles Yes Replace tips Cuvette Integrity pass Cuvette overfill HC waste blocked Wash cuvettes manually No Yes No Replace reagent Per...

Page 254: ...on Check cal values cal prep expiration OK Verify system OK Yes Observed Problem QC Out of Range Recalibrate reblank Rerun QC OK Yes QC prep handling OK Yes Yes Correct errors OK Prepare fresh reagent Rerun QC OK No Accept data Yes No Verify proper reagent handling OK Yes Service No No Prepare fresh controls rerun QC OK No Yes Recalibrate rerun QC OK Yes No 1 2 3 4 5 No No No No Accept data Yes Ye...

Page 255: ...Manufacturer claims for analyte stability Are ranges appropriate to assess system performance Peer group statistics 3 Verify reagent handling Prepared correctly if preparation required Reagent loaded in correct Reagent Carousel and position Expiration date Date reagent was opened and placed onboard Pipettes disposable or washed Workload pattern 4 Check calibrators for the following Correct values ...

Page 256: ...tomer Distribution 256 AEROSET System Troubleshooting Guide 94816 107 November 2004 Check robotic training for sample and reagent arms mixer and ICT module Check for incubator temperature errors Ensure reagent carousels are cold and have puddles of water in compartments ...

Page 257: ...s on the same line 3 Move to opposite line recalibrate OK Yes No Yes Yes Proceed to 4 next page Proceed to 3 Review Run Options calibration checkbox OK Correct recalibrate OK Yes No Yes Yes No Correct recalibrate OK Yes Verify cal targets on CALIBRATOR CONTROL screen OK No No Correct calibrator target recalibrate OK Cycle power calibrate OK Yes No Delete reinstall assay calibrate OK Service No Pro...

Page 258: ...dy done proceed to 6 4 Open new lot of reagent recalibrate OK Stop Open new lot of calibrators recalibrate OK Yes No No Yes No Is cuvette washer dripping or overflowing cuvettes Yes Replace poppet valve or look for obstruction in HC waste tubing Resolved No No Service Yes Yes No Stop No Open new lot of calibrators recalibrate OK If already done proceed to 6 No Yes Yes No Yes Proceed to QC OOR Flow...

Page 259: ...llation date No Yes Replace ICT module Yes Yes ICT module 1 Onboard two months 2 More than 15 000 samples 3 Past expiration date Proceed to Bubbles in ICT Flowchart Error Log Message with 1 02ER000 software Error Log Message with 1 02ER000 software Remove bubbles with applicator stick recalibrate OK Verify calibrator positions target values correct cals used open exp dates All OK Bubbles in calibr...

Page 260: ... IRef tubing not in solution Twisted No Reposition untwist tubing into IRef solution bottle Replace IRef solution filter at end of tubing Quarterly Maintenance IRef cup draining filling correctly Perform preheater test No Yes Inspect Sample A probe Bent Damaged Build up Yes Clean replace Sample A probe No Inspect R1A probe Bent Damaged Build up Service Replace R1A probe Yes Verify IRef solution lo...

Page 261: ...pump valve loose Reconnect and or replace syringe if needed Perform the Wash ICT with IRef and Drain Fill IRef Cup options of the START UP Procedure If the 1 mL syringe is replaced refer to the 1 mL Syringe Replacement Procedure in Section 9 of the Operations Manual Bubbles gone Other Possibilities y ICT aspiration tubing damaged y ICT aspiration pump defective y IRef solution filter needs to be c...

Page 262: ... Bar codes selected Power cycled Yes Correct sample position Bar code damaged No Yes Select bar codes guest log on Cycle power to AEROSET No Yes Power Bar code configuration OK Make new bar code or run manually No No Edit Barcode Length Skip ID field Cycle power Yes No Attempt run Resolved Yes Yes No Yes Yes No No Contact LIS support Stop Stop Proceed to 4 next page Proceed to 4 next page No Proce...

Page 263: ...rough it or not BLUE Host cable connected Connect cable Cycle power Verify configuration matches on Host AEROSET Changes required Make changes cycle power Run Resolved Yes Run debug Change to AEROSET configuration required Yes Cycle power No No Yes Contact LIS Vendor Evaluate debug consult LIS support Yes 5 No Yes No No Stop Service No Yes Run Resolved Run Resolved No Host suspended Yes No Yes Res...

Page 264: ... Outlet has power Yes 1 Check tubing connections crimps 2 Clean replace filter if necessary 3 Cycle power to Analyzer 4 Flush lines on START UP screen Service External water prior to carboy Yes Air still present Carboy overflow Check input pressure 30 to 40 psi desired Adjust if necessary Pull up cap Does water flow Yes Yes No Check external water supply OK Yes Service Proceed to B No Flush water ...

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