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Abbott AEROSET Troubleshooting Manual
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Abbott AEROSET Troubleshooting Manual

Abbott AEROSET Troubleshooting Manual

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System
Troubleshooting
Guide
Abbott Laboratories
©1998, 2004 Abbott Laboratories
Abbott Park, IL 60064
AEROSET is a Registered Trademark of
94816-107—November 2004
Abbott Laboratories

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Summary of Contents for Abbott AEROSET

  • Page 1 System Troubleshooting Guide Abbott Laboratories ©1998, 2004 Abbott Laboratories Abbott Park, IL 60064 AEROSET is a Registered Trademark of 94816-107—November 2004 Abbott Laboratories...
  • Page 2 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution NOTES ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 3: Revision Status

    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 ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 4: Highlights Of Changes From Previous Aeroset System

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution Highlights of Changes from Previous AEROSET System Troubleshooting Guide (94819-106) NOTE: This section is intended as a guide to highlight major and significant changes to this version of the AEROSET System Troubleshooting Guide, Part Number 94816-107.

  • Page 5: Specific Changes And/Or New Information

    Troubleshooting Guide was eliminated because it duplicated information that is readily available to customers in other secondary labeling, e.g., Abbott Clinical Chemistry Package inserts or the AEROSET System Operations Manual. Major sections that were eliminated include: 1. Specific SmartWash™ parameters 2.
  • Page 6 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 settings in System Configuration. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 7: Table Of Contents

    Revision Status ........3 Highlights of Changes from Previous AEROSET System Troubleshooting Guide (94819-106) .
  • Page 8 SmartWash Parameters ......84 SmartWash for Non-Abbott Reagent Applications ..84 Specific Proteins Assays .
  • Page 9 Procedure ......93 Limit of Detection for Abbott Assays Data Sheet . . 94 Limit of Detection for Abbott Assays Data Sheet Example .
  • Page 10 Barbiturates ........110 Cross Reactivity Testing Performed on the AEROSET System by SYVA .
  • Page 11 Methadone ........151 Cross Reactivity Testing Performed on the AEROSET System by SYVA .
  • Page 12 Software ..........171 Color Coding on the AEROSET System ....173 Exporting Files .
  • Page 13 Cuvette Blank Screen ......209 Cuvette Integrity Check Screen ....210 ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 14 Hardware ..........221 CPU Used with the AEROSET System ....223 Cuvettes .
  • Page 15 Troubleshooting Flowcharts ........245 Abbott Assay—Basic Assay Troubleshooting ... 247 Assay Characteristics .

  • Page 16: Proprietary Statement

    Abbott Laboratories technical sales and service representatives. In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred in connection with, or arising from use of information in this document by persons not fully trained by Abbott Laboratories as technical sales and service representatives.

  • Page 17: Master Table Of Contents/Index Disclaimer

    All Abbott Laboratories product names and trademarks are owned by or licensed to Abbott Laboratories, its subsidiaries, or affiliates. No use of any Abbott trademark, 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.
  • Page 18 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Not for Customer Distribution NOTES ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 19: Assays/Reagents

    Assays/Reagents Assays/Reagents ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 20 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution NOTES ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 21: General Information

    Refer to the most current version of Technical Bulletin 1018-2003 when installing new assays. Drugs of Abuse (DOA) Assays The Abbott Clinical Chemistry Drugs of Abuse (DOA) menu includes Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cannabinoids, Cocaine, Ethanol, Methadone, Opiates, Phencyclidine, and Propoxyphene.

  • Page 22: Qualitative Assay Configuration

    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>. Refer to Print Options, Absorbance Mode in this section for additional information. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 23: Print Options

    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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 24 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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 25: Printout

    - 17 Benz - 24 Meth - 30 Barb 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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 26: Factor Mode-Pos/Neg Results

    Assay Configuration screen displays. 4. The Outline page is the default view. Select Figure 3: Assay Configuration Screen, Outline Page 5. Quantitative Ranges is the default setting. Select the checkbox ( ) next to Qualitative Ranges. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 27 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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 28: Printout

    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. NOTE: A result of “0” would be reported as a positive result. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 29: Absorbance Mode

    4. The Outline page is the default view. Select Figure 5: Assay Configuration Screen, Outline Page 5. Verify Quantitative Ranges is selected ( ). This is the default setting. 6. Edit the L-Reference field from “-9999” to “0.0”. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 30 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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 31: Printout

    0.3870 0.3889 Negative The Barbiturates and Cannabinoids (THC50) assays in this example would be reported as positive. Amphetamine/Methamphetamine, Benzodiazepines, Cocaine, Methadone, Opiates 300, Opiates 2,000, Phencyclidine, and Propoxyphene would be reported as negative. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 32: Summary Of Print Options

    ICT assays. If the concentrations are not defined: • ICT buttons do not display on the SELECT ASSAYS FOR CALIBRATION screen. • Calibration Summary report does not print the ICT Cal L values. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 33: Biohazardous Waste

    Dispose of waste in accordance with appropriate waste 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...

  • Page 34: Calculated Assay Results

    8. Select <ReCalc> in the right column. The Recalc dialog window displays. 9. Select <Select Assay> then select the ratio to be recalculated on the SELECT ASSAYS screen. 10. Select <OK>. The ratio is calculated from the rerun assay data. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 35: Calibration Information

    Verifiers I and II and control results should show appropriate responses relative to one another, as shown: Verifier I < – 25% Control < Cutoff Calibrator < + 25% Control < Verifier II ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 36: November

    Propoxyphene Propoxyphene 1,000 NOTE: The Opiates 300 calibrator contains methamphetamine. This does not interfere with the Opiates 300 assay. Refer to the assay-specific package inserts for additional information on calibration, verifiers, and controls. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 37: Factor

    The factor is specific for the ® AEROSET and c 8000 Systems, and optical characteristics of these systems. Enzyme Entered in the Factor field on the Calibration Factor page of the Assay Configuration screen.

  • Page 38: Use Cal Factor From

    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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 39: Calibrators

    CAL 1: 1 x 5 mL Carb 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 ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 40 CAL 2: 1 x 2 mL CAL 3: 1 x 2 mL CAL 4: 1 x 2 mL CAL 5: 1 x 2 mL Opiates 300 2G92-02 1 x 14 mL Opi3 ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 41 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 CAL 6: 1 x 1 mL ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 42: Chemical Reactions For Clinical Chemistry Assays

    L-Alanine + α-Ketoglutarate Pyruvate + L-glutamate Do not use plasma Pyruvate + NADH L-lactate + NAD samples collected using ammonium heparin. LD = Lactate dehydrogenase NADH = Nicotinamide adenine dinucleotide ® * MULTIGENT assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 43 L-Aspartate + α-Ketoglutarate Oxaloacetate + L-glutamate Do not use plasma samples collected Oxaloacetate + NADH L-Malate + NAD using ammonium heparin. MD = Malate dehydrogenase NADH = Nicotinamide adenine dinucleotide ® * MULTIGENT assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 44 G-6-PD-Benzodiazepines (Active) + NAD + Glucose-6-phosphate Does not correlate NADH + 6-phosphogluconate ® well with AxSYM Benzodiazepines G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial source assay. NADH = Nicotinamide adenine dinucleotide ® * MULTIGENT assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 45 PEG = Polyethylene glycol Must not be on the same line as the Lipase assay. 2 Arsenazo III + Ca Ca-Arsenazo complex (blue-purple) New reference range: 9.0 to 10.4 mg/dL. ® * MULTIGENT assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 46 ATP + Glucose ADP + Glucose-6-phosphate R1 contains N-acetylcysteine; G-6-PD therefore, this is a G-6-P + NADP 6-phosphogluconate + NADPH “NAC” CK method. HK = Hexokinase G-6-PD = Glucose-6-phosphate dehydrogenase ® * MULTIGENT assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 47 This method is not CRP (Sample) + Buffer (R1) + Antibody to CRP adsorbed to latex particles (R2) suitable for Turbidity due to agglutination of CRP:Antibody:Particle complex high-sensitivity (HS) measurements. ® * MULTIGENT assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 48 Not for Customer Distribution Assay Reaction Tips Name CAP survey results show a 38.2% CV for 16 different chemistry methodologies. The AEROSET System produces higher biliverdin values than most other analyzers. A factor may be Sodium Nitrite DBil Bilirubin Biliverdin entered to adjust.
  • Page 49 L-γ-glutamyl-3-carboxy-4-nitroanilide + glycylglycine AEROSET System. Abbott has documentation to L-γ-glutamyl-glycylglycine + 3-carboxy-4-nitroaniline support this bias and the accuracy of the AEROSET values. The AEROSET methodology utilizes the IFCC method. Glucose + ATP Glucose-6-Phosphate + ADP G-6-PD Glucose-6-phosphate + NADP...
  • Page 50 PEG = Polyethylene glycol IgM + PEG/buffer (R1) + Antibody to IgM (R2) Turbidity due to Samples containing IgM:Antibody complex high IgM can have increased viscosity. PEG = Polyethylene glycol ® * MULTIGENT assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 51 When correlating, verify whether the comparison method L-lactate + NAD Pyruvate + NADH + H is L P or P since AEROSET LD utilizes the forward NADH = Nicotinamide adenine dinucleotide reaction (L which gives lower results (U/L). ® * MULTIGENT assay ®...
  • Page 52 -80°C. DSBmT = N,N-bis(4-sulphobutyl)-m-toluidine-disodium 4-AAP = 4-Aminoantipyrine There are reports of Lipase interference by 1,2 Diglyceride + H 2-Monoglyceride + fatty acid non-Abbott HDL methods. Correct MGLP 2-Monoglyceride + H Glycerol + fatty acid SmartWash™ configuration is critical for some...
  • Page 53 NADH = Nicotinamide adenine dinucleotide for calibration. Prealbumin + PEG/buffer (R1) + Antibody to prealbumin (R2) Serum samples only. Turbidity due to prealbumin:Antibody complex Alternate test PAlb method: nephelometry. PEG = Polyethylene glycol ® * MULTIGENT assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 54 NADH + 6-phosphogluconate validate the system by analyzing controls. G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial source NADH = Nicotinamide adenine dinucleotide Phos Phosphate + molybdate Heteropolyacid complex ® * MULTIGENT assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 55 G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial source NADH = Nicotinamide adenine dinucleotide RF (Sample) + Buffer (R1) + Antibody to RF adsorbed to latex particles (R2) Turbidity due to agglutination of RF:Antibody:Particle complex Abbott reagent LN 8G62-20 is the TBil same reagent...
  • Page 56 Certain types of plastics adsorb cannabinoids (THC) from solutions, decreasing the concentration. To prevent adsorbtion: • Fill AEROSET sample cups with Antibody to THC (R1) + G-6-PD-THC (R2) (Active) 600 µL to G-6-PD-THC:Antibody complex (Inactive) minimize surface-to-volume G-6-PD-THC:Antibody complex (Inactive) + UC ratio.
  • Page 57 Total Protein assay, a biuret method. Plasma -Protein Nitrogen complex values are generally (Biuret reaction) 0.3 to 0.5 g/dL higher than serum values, due to the presence of fibrinogen. ® * MULTIGENT assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 58 CSF. Urease Urea + H + CO + α-Ketoglutarate + NADH Urea Glutamate + NAD NADH = Nicotinamide adenine dinucleotide GLD = Glutamate dehydrogenase ® * MULTIGENT assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 59 Uric recover at approximately 50% TBHB = 2,4,6 Tribromo-3-hydroxy benzoic acid for the highest level 4-AAP = 4-Aminoantipyrine on the AEROSET System. The same is seen with Roche assays run on the Roche/Hitachi. Verichem linearity was able to recover at 100%.

  • Page 60: Drugs Of Abuse (Doa) Assays

    • Free base Benzoylecgonine, Flake, Blow, Crack form—rocks 3-Methyl- (“dime ecgononine, rocks”) Ecgonine • White powder Ethanol Ethanol, beer, wine, Booze, Hooch, Sauce Liquid, Acetaldehyde, liquor, Everclear flavorings acetic acid added for taste ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 61 • Other: tablets, liquid, powder, and injectable forms Phencyclidine None Angel Dust, Hog, Fine white PCP and Killer Weed (when powder metabolites used on marijuana) Propoxyphene Darvon, Darvocet-N Yellow Footballs Capsules, Propoxyphene tablets norpropoxyphene ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 62 14 days syndrome, mental activity (brownie, decreased • Large person, salad) emotional chronic user: development, up to 30 days increased (based on susceptibility to 25 ng/mL disease detection limit) ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 63 (euphoria) • “Good sick”: nauseous but it feels pleasurable • “Nod”: central nervous system (CNS) depression, drowsiness • Withdrawal: watery eyes, salivation, GI symptoms, discomfort, agitation ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 64 (nystagmus), muscle contractions uncoordinated (spasms) movement (ataxia) Propoxyphene Orally, 7 days • Acute: abnormal Addiction, overdose, intravenously sense of death well-being (euphoria), drowsiness, slurred speech • Withdrawal: agitation, seizures ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 65: Cross Reactivity

    System, the package insert describes rate results between the cutoff rate and ± 25% rate, also the ± 50% rate. For the AEROSET System, only results between the cutoff rate and ± 25% rate are discussed, not the ± 50% rate. This is...

  • Page 66: Multigent ® Assays

    ® MULTIGENT Assays General Information MULTIGENT assays are supplied to Abbott from Original Equipment Manufacturers (OEM) and include Abbott Laboratories as the distributor on all MULTIGENT labeling. The MULTIGENT assay menu, including OEM supplier information, is listed in the following table.

  • Page 67: Plasma Claims For Gel Barrier Tubes

    Clarification—plasma tubes with a gel barrier were not tested; therefore, no claim is made for these types of tubes. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 68: Proficiency Testing

    AAB Reagent Codes Analyte Code Methodology Albumin BCG Abbott bromcresol green Albumin BCP Abbott bromcresol purple Alkaline Phosphatase Abbott no DEA 37°C Abbott no P5P 37°C Amylase Abbott CNPG substrate Abbott no P5P 37°C Bicarbonate (CO Abbott UV/serum blanks Bilirubin, Total...

  • Page 69: Cap Codes

    Albumin BCG 1099 Bromcresol green/dye binding Albumin BCP 1101 Bromcresol purple/dye binding Alkaline Phosphatase 1518 Abbott/37°C 1518 Abbott/37°C ALT Activated 1526 Abbott pyridoxal phosphate activated reagent/37°C Amylase 1518 Abbott/37°C Apolipoprotein A1 1241 Immunoturbidimetric Apolipoprotein B 1241 Immunoturbidimetric 1518 Abbott/37°C AST Activated...
  • Page 70 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution Analyte Methodology Code Hemoglobin A 1055 Abbott AEROSET HDL, Direct 1757 Liquid selective detergent (enzymatic) Iron 1207 FERENE without a protein removal step Lactate Dehydrogenase 1518 Abbott/37°C (LD) Lactic Acid 1321...

  • Page 71: Urine Survey

    Methodology Code C-Reactive Protein 1637 Turbidimetric/immunoturbidimetric Complement C3 1637 Turbidimetric/immunoturbidimetric Complement C4 1637 Turbidimetric/immunoturbidimetric Haptoglobin 1637 Turbidimetric/immunoturbidimetric Immunoglobulin A 1637 Turbidimetric/immunoturbidimetric Immunoglobulin G 1637 Turbidimetric/immunoturbidimetric Immunoglobulin M 1637 Turbidimetric/immunoturbidimetric Rheumatoid Factor 1637 Turbidimetric/immunoturbidimetric ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 72: Therapeutic Drug Monitoring

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution Therapeutic Drug Monitoring Analyte Methodology Code Carbamazepine 3254 Abbott AEROSET Digoxin* 3254 Abbott AEROSET Phenobarbital 3254 Abbott AEROSET Phenytoin 3254 Abbott AEROSET Theophylline 3254 Abbott AEROSET Valproic Acid* 3254 Abbott AEROSET ®...

  • Page 73: Quality Control

    L-2: 695 12 x 3 mL L-3: 696 12 x 3 mL AlkP Crea ETOH PAlb ApoA Pheno ApoB Pheny Hapt Phos BilD Theo BilN TIBC BilT Iron Trig Urea Carb Lact Uric Chol ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 74 L-3: 503 6 x 2 mL shelf life and control ranges may need to be reestablished. Control Level 1 varies in concentration. Recommendation: Do not use Level 1 if < 15 IU/mL. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 75 12 x 5 mL Iron L-3: 363 Liquichek Therapeutic Drug Trilevel: 724 12 x 5 mL Carb Pheno Theo Monitoring Control L-1: 725 12 x 5 mL Pheny L-2: 726 12 x 5 mL L-3: 727 ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 76: Ordering Information

    Biochemical Diagnostics, Inc. East Coast (800) 223-4835 or (631) 595-9200 support@biochemicaldiagnostics.com West Coast (800) 223-8803 bcdw@biochemicaldiagnostics.com Worldwide Web www.biochemicaldiagnostics.com ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 77: Establishing Quality Control Limits

    Not for Customer Distribution Establishing Quality Control Limits Use the following instructions to establish quality control limits for Abbott Clinical Chemistry assays. Temporary Quality Control Limits 1. Enter the assay parameters for the appropriate new assay. 2. Calibrate and run three replicates each of a multi-level control in a single run.

  • Page 78: Permanent Control Limits

    Recalibrate whenever a control fails or every 14 calendar days. Record control results. Do not discard any result unless it was generated by operator error or instrument malfunction, or results can be rejected as a statistical outlier. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 79: Temporary Control Limits Worksheet

    Control 1 Control 2 Control 3 Accepted by Mean (x) 20% of Mean (x) (0.20) Lower Limit (x – 20%) Upper Limit (x + 20%) Temporary control limits accepted by: Name: ____________________________________________________ Date: _______________________ ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 80: Reagent Test Count Tracking

    Not for Customer Distribution Reagent Test Count Tracking Reagent Test Counts The AEROSET System performs a level sense in the reagent cartridge and calculates the remaining volume of reagent. The dead volume (based on the height of the low aspiration limit) and the configured reagent volume plus over-aspiration is subtracted from the reagent volume;...

  • Page 81: Sample Blanking

    Sample Blank Test field. The Blank Read Time fields must remain zero. When the assay is ordered, the AEROSET System dispenses the sample and reagent defined in the assay...

  • Page 82: Sample Interference Indices

    Not for Customer Distribution Sample Interference Indices The Sample Interference Indices Protocol is available on the AEROSET Assay Disk, Assays > 50 (LN 2K15 and 2K16). This feature allows semi-quantitative or qualitative estimates (index values) for the presence of hemolysis, icterus, or lipemia (turbidity) in serum or plasma samples.

  • Page 83: Smartwash

    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.

  • Page 84: Smartwash Parameters

    Not for Customer Distribution SmartWash™ Parameters When a SmartWash is configured for the reagent probe, the AEROSET System attempts to schedule the assay so the two assays are separated by another reagent, maximizing throughput and eliminating need for the wash.

  • Page 85: Specific Proteins Assays

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution Specific Proteins Assays The Abbott Clinical Chemistry Specific Proteins menu includes Apolipoprotein A1 and B; Complement C3 and C4; Haptoglobin; Immunoglobulin A, G, and M; Prealbumin; and Transferrin. Imprecision • The R2 component of two-reagent assay contain the active ingredient •...

  • Page 86: Frequently Asked Questions (Faq)

    • Linear assays (ApoA, ApoB, and PAlb): accuracy above the highest calibrator is dependant on calibrator concentrations, which vary from lot to lot. The AEROSET System uses %EXT to prevent extrapolation. Although R&D testing supports linearity beyond the highest calibrator, linearity was defined up to the high calibrator.

  • Page 87: November

    When running the IgA or IgM assay, and an The sample should be rerun undiluted. An LL Result Error Code occurs, what should the automated dilution can be performed using customer do? Dil 1. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 88: Specimen Collection And Handling

    Serum should be separated within two hours of collection, and prolonged contact of serum with the clot will affect potassium, glucose, and ammonia results. Reference: McClatchey KD, editor. Clinical Laboratory Medicine, 1st ed. Philadelphia, PA: Lippincott, Williams, and Wilkins, 1994:85. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 89: Therapeutic Drug Monitoring (Tdm) Assays

    • 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 sample cup. Troubleshooting Tips The following issues may impact TDM assay results: •...

  • Page 90: Frequently Asked Questions (Faq)

    8000 and AEROSET Systems. Testing was repeated on the AEROSET for all four assays because of additional requirements for a daily blank calibration and calibration with each new wedge.
  • Page 91 This is especially true in renal insufficiency, where HPPG clearance is decreased and plasma levels of HPPG may be increased 10 times the phenytoin concentration. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 92: Verification Procedures

    Before performing the study, the following conditions must be met: • Maintenance procedures are up to date. • Reagent and samples are available in sufficient quantity. • Assays are calibrated. • All control levels are in range. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 93: Procedure

    10. Select <RUN> in the Action Area of the Main Display. The RUN OPTIONS screen displays. 11. Select the Patient option ( ). 12. Select <Start> in the right column of the RUN OPTIONS screen to initiate the run. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 94: Limit Of Detection For Abbott Assays Data Sheet

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution Limit of Detection for Abbott Assays Data Sheet Date: _____________ Analyte: ___________________________________________________________ Instrument: ___________________________________________ Serial No.: ______________________ Lot Number Expiration Date Reagent Kit Calibrators Record the values for the zero concentration sample replicates.

  • Page 95: Sheet Example

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution Limit of Detection for Abbott Assays Data Sheet Example Date: 3/11/03 Analyte: Instrument: AEROSET System Serial No.: 1243 Lot Number Expiration Date Reagent Kit 334455MB 07/07/03 Calibrators 50383 05/01/03 Record the values for the zero concentration sample replicates.

  • Page 96: Confirming The Limit Of Quantitation (Loq)

    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...
  • Page 97 10. Select <RUN> in the Action Area of the Main Display. The RUN OPTIONS screen displays. 11. Select the Patient option ( ). 12. Select <Start> in the right column of the RUN OPTIONS screen to initiate the run. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 98: Sheet

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution Limit of Quantitation for Abbott Assays Data Sheet Date: _____________ Analyte: ___________________________________________________________ Instrument: ___________________________________________ Serial No.: ______________________ Lot Number Expiration Date Reagent Kit Calibrators Record the values for the low analyte sample replicates.

  • Page 99: Sheet Example

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution Limit of Quantitation for Abbott Assays Data Sheet Example Date: 3/11/03 Analyte: Instrument: AEROSET System Serial No.: 1243 Lot Number Expiration Date Reagent Kit 334455MB 07/07/03 Calibrators 50383 05/01/03 Record the values for the low analyte sample replicates.
  • Page 100 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution NOTES ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 101: Assay-Specific Information

    40.39, 29.19 U/L by AEROSET). Method comparison data for AEROSET and Paramax yielded the following least squares equation: AEROSET = 3.61 (Paramax) - 2.96, r = 0.992, N = 78 When the same data were analyzed using Passing-Bablok, the equation was: AEROSET = 2.86 (Paramax) - 1.59, r = 0.992, N = 78...

  • Page 102: November

    Not for Customer Distribution Although Paramax and AEROSET assays definitely correlate (as shown by the r value), a specimen tested on the AEROSET will yield a value approximately three times greater than that obtained by the Paramax System. The Paramax uses...

  • Page 103: Albumin Bcg

    Not for Customer Distribution Albumin BCG Calibrators Do not use Multiconstituent Calibrator CAL 1 (MCC 1) for calibration. Use MCC 2 for both CAL 1 and 2. The AEROSET System automatically dilutes MCC CAL 2 for CAL 1. Observed Problem Illegal assay configuration...

  • Page 104: Alt

    However, ALT Activated and AST Activated assays require reconstitution, and have shorter onboard stability than the non-activated assays—seven days vs. 27 days. ALT Activated Ammonium Heparin Tube Not Acceptable Refer to ALT in this section for details. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 105: Amphetamine/Methamphetamine

    Assays/Reagents Not for Customer Distribution Amphetamine/Methamphetamine Cross Reactivity Testing Performed on the AEROSET System by SYVA Compounds listed in the following table yielded a negative result at 1,000 ng/mL d-methamphetamine (Multi DOA Cutoff calibrator) when tested at the concentration listed.

  • Page 106: Amylase

    No testing has yet been conducted for the specific amylase method 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...

  • Page 107: Apolipoprotein A1

    Reagent container bar code label not read Probable Cause(s) Corrective Action(s) Bar code label not positioned Check positioning of the R1 and R2 reagent correctly. bottles; verify the bar code label is facing the center of the carousel. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 108: Apolipoprotein B

    Reagent container bar code label not read Probable Cause(s) Corrective Action(s) Bar code label not positioned Check positioning of the R1 and R2 reagent correctly. bottles; verify the bar code label is facing the center of the carousel. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 109: Ast

    (%CV = 20), rather than using the LOD which represents the noise associated with the analytical system in the absence of analyte. An in-house normal range study is planned. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 110: Barbiturates

    Assays/Reagents Not for Customer Distribution Barbiturates Cross Reactivity Testing Performed on the AEROSET System by SYVA Compounds listed in the following table yielded a negative result at 200 ng/mL secobarbital (Multi DOA Cutoff calibrator) when tested at the concentration listed.
  • Page 111 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution SYVA Package Insert Compound µg/mL Nortriptyline Promethazine 1,000 Ranitidine Scopolamine Tramadol Tyramine Zidovudine (AZT) 2 mg/mL Zolpidem ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 112: Benzodiazepines

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution Benzodiazepines Cross Reactivity Testing Performed on the AEROSET System by SYVA Compounds listed in the following table yielded a result approximately equivalent to the Multi DOA Cutoff calibrator (200 ng/mL lormetazepam). Concentration...
  • Page 113 µg/mL (Tested at 150 ng/mL Cutoff) Fluoxetine Glutethimide Ketamine Ketorolac tromethamine 1,000 Lysergic acid diethylamide (LSD) 10 ng/mL Meperidine 1,000 Nortriptyline Phenytoin 1,000 Promethazine 1,000 Ranitidine Scopolamine Thioridazine Tramadol Tyramine Zidovudine (AZT) 2 mg/mL Zolpidem ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 114: Calcium

    Probable Cause(s) Corrective Action(s) Reagent cross contamination. Run Calcium in batch mode for LOD/LOQ testing. NOTE: Creatinine contaminates Calcium at very low levels, even with SmartWash™ configured. The contamination is not clinically significant. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 115: Cannabinoids

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution Cannabinoids Cross Reactivity Testing Performed on the AEROSET System by SYVA Compounds listed in the following table yielded a negative ∆ result at 50 ng/mL 11-nor- -THC-9-carboxylic acid (Multi DOA Cutoff calibrator) when tested at the concentration listed.

  • Page 116: Troubleshooting Imprecision

    Certain types of plastics adsorb cannabinoids (THC) from solutions, decreasing the concentration. Observe the following guidelines to prevent adsorption. • AEROSET sample cups should be filled with 600 µL of calibrator, control, or specimen to minimize the surface-to-volume ratio. •...

  • Page 117: Cocaine

    Assays/Reagents Not for Customer Distribution Cocaine Cross Reactivity Testing Performed on the AEROSET System by SYVA Compounds listed in the following table yielded a negative result at 300 ng/mL benzoylecgonine (Multi DOA Cutoff calibrator) when tested at the concentration listed.
  • Page 118 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution SYVA Package Insert Compound µg/mL (Tested at 150 ng/mL Cutoff) Promethazine 1,000 Ranitidine Scopolamine Thioridazine Tramadol Tyramine Zidovudine (AZT) 2 mg/mL Zolpidem ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 119: Complement C3

    Reagent container bar code label not read Probable Cause(s) Corrective Action(s) Bar code label not positioned Check positioning of the R1 and R2 reagent correctly. bottles; verify the bar code label is facing the center of the carousel. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 120: Complement C4

    Reagent container bar code label not read Probable Cause(s) Corrective Action(s) Bar code label not positioned Check positioning of the R1 and R2 reagent correctly. bottles; verify the bar code label is facing the center of the carousel. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 121: C-Reactive Protein

    The LOQ claim is 0.50 mg/dL in the CRP The LOQ study yielded representative data of package insert. The insert also states that a 0.25 mg/dL (worst case result observed). The study was performed on the AEROSET and claim of 0.50 mg/dL is the Product ® ®...
  • Page 122 We do not have data for this. However, CAP a proficiency survey are compared to other Proficiency Survey specimens were recently manufacturers’ CRP assays? run at Abbott, as they are for all on-market products. We will review the results and communicate them internally when published by CAP.
  • Page 123 However, it was verified that the EXT and High flags work appropriately with CRP. Why do AEROSET CRP control means listed Precision studies for the AEROSET and c 8000 in the Precision section of the package insert Systems were done at different times with ®...
  • Page 124 Logically, less lamp intensity would translate as additional turbidity, and therefore higher concentration. Were any study data generated with a diminished lamp? ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 125: Creatine Kinase

    However, because of the nature of the CK assay, this condition does not occur, and the Flex Read Time is never utilized by the AEROSET System for the CK assay. Linearity of CK is 4,267 U/L. To obtain a higher value than 4, 267, the result can be auto diluted 1:2 or 1:10 using the dilution protocols defined for the CK assay.

  • Page 126: Cross Reactivity

    0.0% Quinidine sulfate 100,000 0.0% dihydrate Salicylate 1,000,000 0.0% Secobarbital 100,000 0.0% Testosterone 5,000 0.0% NOTE: Test results were obtained with an alternate assay configuration with the same antibody as ® MULTIGENT Digoxin. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 127: Sample Carryover

    Which controls are recommended? Which Bio-Rad Liquichek TDM control has been used controls have AEROSET assay values? 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: Direct Ldl (Multigent)

    • The calibrator is traceable to the National Reference System for Cholesterol, NRS/CHOL. • The calibrator is supplied with the reagent, and cannot be ordered separately. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 129: Linearity Verifiers (80-5953-00, 2 X 3 Ml)

    Calculate the %recovery for each sample: %recovery = (mean result/theoretical result) × 100. f. Each sample value should be within ± 10% of the theoretical value. If not, evaluate the clinical significance. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 130 694 (= 40% Mean 102% Result × 1.5) 694 (= 40% Mean 101% Result × 2.0) 868 (= 40% Mean 102% Result × 2.5) The reportable range has been verified up to 868 mg/dL. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 131: Frequently Asked Questions (Faq)

    1. Run multiple reps of sample to confirm the aligned, bent, etc.). problem exists. 2. If problem still exists, troubleshoot the sample probe. Refer to Section 10, Troubleshooting and Diagnostics of the AEROSET System Operations Manual. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 132: Ethanol

    Adjust the R2 reagent arm over the cuvette. the cuvette. If R2 reagent is dispensed Refer to Reagent Arm Adjustment in the down the side of the cuvette, Hardware section of this guide. complete reagent/sample mixing does not occur. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 133: Haptoglobin

    Reagent container bar code label not read Probable Cause(s) Corrective Action(s) Bar code label not positioned Check positioning of the R1 and R2 reagent correctly. bottles; verify the bar code label is facing the center of the carousel. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 134: Hemoglobin A 1C (Multigent ® )

    Complex (Reagent 1) :Antibody:Microparticle Complex (higher rate of agglutination—decreased absorbance rate) Hemoglobin A concentration is inversely proportional to absorbance change. High absorbance change = low HbA concentration; low absorbance change = high HbA concentration. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 135: Pretreatment (Hemolysate Preparation)

    5. Mix by gently vortexing at medium speed 5 to 10 seconds. Avoid foaming. 6. Prior to testing, allow the hemolysate to incubate for at least 5 minutes at 15 to 30°C. 7. Transfer hemolysate to a sample cup and place on the instrument. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 136: Accuracy By Recovery Of Standards

    0.01 0.89 0.89 0.99 1.00 0.01 1.27 1.23 -0.04 1.54 1.57 0.03 1.80 1.85 0.05 2.06 2.06 The spline method of calibration matches the theoretical calculation value at the midpoints of the curve. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 137: Hemoglobin Denaturant Storage Conditions

    3. The pipet tip was wiped clean on the outside, with precautions taken to not wick any sample. 4. Blood was dispensed into denaturant and the tip was rinsed two times. 5. The treated sample was vortexed at medium speed approximately five seconds. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 138: Pipet Mix

    Prep 1, Rep 2 Prep 2, Rep 1 Prep 2, Rep 2 Prep 3, Rep 1 Prep 3, Rep 2 Mean There is no difference in the final HbA result based on mixing method. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 139: Interference Information

    Bio-Rad Variant A — — — Bio-Rad Variant GHb Yes/No — Conflicting Bio-Rad Variant II A data in literature — — — Helena Glyco-Tek Yes/No Conflicting Menarini HA8140 data in literature — Primus CLC 330/385 ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 140 Trait Trait Trait — — — Provalis Glycosal (Bio-Rad MicroMat) — — — Roche Cobas Integra Roche Tina-quant II — — Roche Unimate — Yes/No Conflicting Tosoh A 2.2 Plus data in literature ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 141: Frequently Asked Questions (Faq)

    HAMA (human anti-mouse antibodies), hemolysis, bilirubin, and lipemia. Which controls are recommended? Which MULTIGENT Hemoglobin A controls, controls have AEROSET assay values? LN 2K96-10, are recommended for the Hemoglobin A assay. Refer to the MULTIGENT Hemoglobin A Control value sheet for control ranges.
  • Page 142 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 Studies were run on assays most sensitive to assay configuration.

  • Page 143: Ict

    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 Manual for initial recovery from Error Log Messages 88, 351, and 352. ®...

  • Page 144: Immunoglobulin A

    Reagent container bar code label not read Probable Cause(s) Corrective Action(s) Bar code label not positioned Check positioning of the R1 and R2 reagent correctly. bottles; verify the bar code label is facing the center of the carousel. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 145: Immunoglobulin G

    Reagent container bar code label not read Probable Cause(s) Corrective Action(s) Bar code label not positioned Check positioning of the R1 and R2 reagent correctly. bottles; verify the bar code label is facing the center of the carousel. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 146: Immunoglobulin M

    • Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge. • Check reagent adapters to verify they are seated properly. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 147 Reagent container bar code label not read Probable Cause(s) Corrective Action(s) Bar code label not positioned Check positioning of the R1 and R2 reagent correctly. bottles; verify the bar code label is facing the center of the carousel. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 148: Iron

    Kempinaire A, Laureys M, Goedhuys W, et al. Spuriously low concentrations of serum iron measured with Generation 14 Kodak Ektachem slides: prevalence, possible causes, and partial improvement with Generation 16 slides, Clin Chem 1992; 38:2457–64. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 149: Magnesium

    Magnesium calibrator values are required. Editing the reporting units does not automatically convert the appropriate parameters. 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.
  • Page 150 2. Edit the following parameters as described in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual. The following example uses values listed in the Abbott Clinical Chemistry Magnesium package insert, Commodity No. 30-3348/R6, March 2004.

  • Page 151: Methadone

    Assays/Reagents Not for Customer Distribution Methadone Cross Reactivity Testing Performed on the AEROSET System by SYVA Compounds listed in the following table yielded a negative result at 300 ng/mL methadone (Multi DOA Cutoff calibrator) when tested at the concentration listed.

  • Page 152: Microalbumin (Multigent)

    1. Check the dryer tip. If the dryer tip is not troubleshooting should be performed? perfectly aligned, residual water or excess protein can remain in the cuvettes. 2. Inspect the sample probe for protein build-up. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 153: Opiates 300

    Assays/Reagents Not for Customer Distribution Opiates 300 Cross Reactivity Testing Performed on the AEROSET System by SYVA Compounds listed in the following table yielded a negative result at 300 ng/mL morphine (Opiates 300 calibrator) when tested at the concentration listed.
  • Page 154 NOTE: Therapeutic doses of ofloxacin (Floxin) 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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 155: Opiates 2,000

    Assays/Reagents Not for Customer Distribution Opiates 2,000 Cross Reactivity Testing Performed on the AEROSET System by SYVA Compounds listed in the following table below yielded a negative result at 2,000 ng/mL morphine (Multi DOA Cutoff calibrator) when tested at the concentration listed.
  • Page 156 NOTE: Therapeutic doses of ofloxacin (Floxin) 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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 157: Phencyclidine

    Assays/Reagents Not for Customer Distribution Phencyclidine Cross Reactivity Testing Performed on the AEROSET System by SYVA Compounds listed in the following table yielded a negative result at 25 ng/mL phencyclidine (Multi DOA Cutoff calibrator) when tested at the concentration listed.
  • Page 158 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution SYVA Package Insert Compound µg/mL Tramadol Tyramine Zidovudine (AZT) 2 mg/mL Zolpidem ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 159: Prealbumin

    Reagent container bar code label not read Probable Cause(s) Corrective Action(s) Bar code label not positioned Check positioning of the R1 and R2 reagent correctly. bottles; verify the bar code label is facing the center of the carousel. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 160: Propoxyphene

    Assays/Reagents Not for Customer Distribution Propoxyphene Cross Reactivity Testing Performed on the AEROSET System by SYVA Compounds listed in the following table yielded a negative result at 300 ng/mL propoxyphene (Multi DOA Cutoff calibrator) when tested at the concentration listed.
  • Page 161 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Assays/Reagents Not for Customer Distribution SYVA Package Insert Compound µg/mL Tyramine Zidovudine (AZT) 2 mg/mL Zolpidem ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 162: Rheumatoid Factor

    Standard Expected Recovered Assay Units %Recovery Material Value (Mean) Value WHO 64/2 mg/dL 3.92 3.8513 98.25 (LN 8G66) IU/mL 105.73 115.62 109.35 IU/mL 50.93 52.47 103.02 IU/mL 26.43 27.19 102.87 ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 163: Frequently Asked Questions (Faq)

    For the Abbott Clinical Chemistry RF assay application, we used control ranges of approximately 15%. In one case, the control ranges needed to be reset for controls near expiration.
  • Page 164 Will customers have an issue if there are not CAP surveys do not work with RF and should enough Abbott assay users when results from not be used. The cause for this is under a proficiency survey are compared to other investigation.
  • Page 165 Assays/Reagents Not for Customer Distribution Frequently Asked Questions (FAQ) (Continued) Question Response During RF precision studies on the AEROSET None. Excluding data points from the ® and c 8000 , how many points were below the precision study would have prevented...
  • Page 166 However, it was verified that the EXT and High flags work appropriately with CRP. Why do AEROSET RF control means listed in Precision studies for the AEROSET and c 8000 the Precision section of the package insert not Systems were performed at different times ®...

  • Page 167: Total Bilirubin

    Obtain a new sample. Total Protein Interference Information Dextran has been reported to negatively interfere with the Abbott Clinical Chemistry Total Protein assay, a biuret method. The following summary is from the Methods in Clinical Chemistry, 1987, by Laurence A. Kaplan.

  • Page 168: Transferrin

    Reagent container bar code label not read Probable Cause(s) Corrective Action(s) Bar code label not positioned Check positioning of the R1 and R2 reagent correctly. bottles; verify the bar code label is facing the center of the carousel. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 169: Valproic Acid (Multigent ® )

    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 HAMA samples were compared to the mean of the control normal human serum.

  • Page 170: Frequently Asked Questions (Faq)

    Which controls are recommended? Which Bio-Rad Immunoassay Plus controls have controls have AEROSET assay values? 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? This is normal.

  • Page 171: Software

    Section 10: Software System Troubleshooting Guide Software ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 172 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution NOTES ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 173: Color Coding On The Aeroset System

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Color Coding on the AEROSET System Reagent expired or empty/ Reagent Low/ calibration Illegal assay Assay Cal error expired or (Green) (Black) (Yellow) unusable (Pink) Cold Water Bath (Green) (Pink) (Blue)

  • Page 174: Exporting Files

    The following are some examples of this anomaly: • French character é appears as “,” • Spanish character ú appears as “ £ ” To correct the problem, manually edit the affected characters on the spreadsheet. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 175: Host Interface Trace Log

    4. Type dbgmode at the c:\ prompt then press [Enter]. 5. In the drop-down list box next to Online, select <NONE>. 6. Select <OK>. 7. Type exit at the c:\ prompt to return to the Main Display. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 176: Observed Problems-Software

    <START> was selected when the 1. Select <RUN> in the Action Area of the system status was changing from Main Display. The RUN OPTIONS screen SUSPEND to READY. displays. 2. Select <START> to initiate the run. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 177 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 between the Cycle power on both the AEROSET system and AEROSET system and Host interface. Host computer. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 178: Quality Control

    No Flag 100.0 H or No Flag 100.34 100.3 100.45 100.5 100.56 100.6 When the result is 90, it is not known if the actual value was 90.001 (no Flag) or 89.999 (L Flag). ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 179: Qc Statistics-Decimal Places

    Range = Decimal places value Decimal Places Value (Base Page Decimal Places Decimal Places Decimal Places Decimal Places of Assay of Mean Values of SD Values of CV Values of Range Values Configuration Screen) ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 180: Rounding Of Numbers

    Not for Customer Distribution Rounding of Numbers The AEROSET System allows only 7 digits, one of which may be a decimal. When the last digit is 5 or greater, the number rounds up. If the last digit is less than 5, the number rounds down.

  • Page 181: Screen Hierarchy

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Screen Hierarchy ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 182: Information Access Area Of The Main Display

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 183: Screen Navigation

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Screen Navigation Main Display REAGENTS Screen ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 184: Reagents (Supply Center Segment) Screen

    CONFIDENTIAL MATERIAL Software Not for Customer Distribution REAGENTS (Supply Center Segment) Screen Bar Code Scanned (Reagent name text is BROWN) Manually Configured (Reagent name text is BLACK) Reagent Supply Center Segment Details Screen ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 185: Database Screen

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution DATABASE Screen Search Dialog Window Patient Demographics Dialog Window ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 186: Print Options Dialog Window-Order List/Loadlist

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Print Options Dialog Window—Order List/Loadlist Order Samples Screen ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 187: Page Setup Screen (Form 1)

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution PAGE SETUP Screen (Form 1) Form 1 Report ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 188: Page Setup Screen (Form 2)

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution PAGE SETUP Screen (Form 2) Define Free Text Screen ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 189: Form 2 Report

    7.0 - 18.0 12 U/L 10.0 - 35.0 Crea 1.4 mg/dL 0.7 - 12.3 mg/dL 8.4 - 10.2 Phos 2.6 mg/dL 2.7 - TBil 0.8 mg/dL 0.2 - On-line Data Transfer Dialog Window ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 190: Result Screen

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution RESULT Screen RESULT Screen—Viewing Rerun Result ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 191: Reaction Graph Screen-Error Code

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Reaction Graph Screen—Error Code Reaction Graph Screen—Rate Assay ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 192: Reaction Graph Screen-End-Point Assay

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Reaction Graph Screen—End-point Assay Absorbance Data Screen DATABASE Screen, Accept Results Dialog Window ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 193: Calibrator/Control Screen

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution CALIBRATOR/CONTROL Screen CALIBRATOR/CONTROL Screen—Set 1 ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 194: Position Dialog Window

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

  • Page 195: Calibration Details Screen

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Calibration Details Screen QC SUMMARY Screen ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 196: Levey-Jennings Graph Screen

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Levey-Jennings Graph Screen Print Options (QC) Dialog Window ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 197: Levey-Jennings Graph Report

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Levey-Jennings Graph Report QC Details Dialog Window QC Data List Screen ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 198: Assays Screen

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution ASSAYS Screen ASSAY STATUS Screen ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 199: Assay Configuration Screen, Outline Page

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Assay Configuration Screen, Outline Page Assay Configuration Screen, Base Page (End-point Assay) ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 200: Assay Configuration Screen, Base Page (Rate Assay)

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Assay Configuration Screen, Base Page (Rate Assay) Assay Configuration Screen, Calibration Page (Linear Calibration Mode) ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 201: Assay Configuration Screen, Smartwash™ Page

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Assay Configuration Screen, SmartWash™ Page Assay Configuration Screen, Rerun Rules Page ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 202: Run Options Screen

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution 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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 203: Select Assays For Stat Screen

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

  • Page 204: Unpause Function

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

  • Page 205: Shutdown Options Screen

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution SHUTDOWN OPTIONS Screen ERROR LOG Screen Level 1 Level 2 Level 3 (Red) (Pink) (Yellow) ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 206: Maintenance Utilities Screen, System Page

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution MAINTENANCE UTILITIES Screen, System Page NOTE: Zero Set is only visible with guest Log On. MAINTENANCE UTILITIES Screen, SCC Page ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 207: Maintenance Utilities Screen, Sampling Page

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution MAINTENANCE UTILITIES Screen, Sampling Page NOTE: Step Edit is visible only with guest Log On. Pressure Monitor Screen ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 208: Maintenance Utilities Screen, Rgt Area 1 Page

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution MAINTENANCE UTILITIES Screen, Rgt Area 1 Page MAINTENANCE UTILITIES Screen, Rgt Area 2 Page ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 209: Maintenance Utilities Screen, Rxn Area Page

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution MAINTENANCE UTILITIES Screen, Rxn Area Page Cuvette Blank Screen ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 210: Cuvette Integrity Check Screen

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution Cuvette Integrity Check Screen MAINTENANCE UTILITIES Screen, SW Info Page Printer A Configuration Window ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 211: Online (Host) Configuration Dialog Window

    ONLINE (HOST) CONFIGURATION Dialog Window Run Progress Area Log On Screen Without Optional Clot Detection and With Optional Clot Detection and Sample Sample Carryover Reduction Installed Carryover Reduction Installed User Alert Dialog Window ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 212: System Configuration

    10. If set to zero, the FAC Limit check is not performed. For those assays configured on the AEROSET System at the time of software installation, the default setting for the FAC Limit % field is 10.

  • Page 213: System Configuration Software Disk V3.0

    CONFIDENTIAL MATERIAL Software Not for Customer Distribution System Configuration Software Disk v3.0 The AEROSET System Configuration Software Disk v3.0 can only be used with AEROSET software v1.00ER005.0 or v1.00ER005.2. Do not use System Configuration Software Disk v3.0 with AEROSET software v1.02ER000 or greater. Installation of the System Configuration Software Disk v3.0 on a v1.02ER000...
  • Page 214 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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 215: Unit Configuration Default Screen

    Software Not for Customer Distribution Unit Configuration Default Screen The default view of the AEROSET software v1.02ER000 Unit Configuration screen is shown 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.

  • Page 216: Unit Configuration 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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 217: Startup/Shutdown Setting Default Screens

    Software Not for Customer Distribution Startup/Shutdown Setting Default Screens Default views of the AEROSET software v1.02ER000 automatic Startup/Shutdown Setting screen are shown below. Also included is a table that describes fields on the Startup/Shutdown Setting screen which can be affected if the System Configuration Software Disk v3.0 is loaded after...
  • Page 218 Change MCC (Drain & Fill IRef Cup) Clear Database: • Cal, QC • All Results • All Records • Cal, QC, QC Clo • All Res., QC Clo • All Rec., QC Clo ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 219: User Codes/Passwords

    0701 1006 0603 0222 0808 0524 0418 1026 0922 0130 1102 0817 0221 1107 0702 0513 0220 0616 1207 0202 0315 1016 0405 0728 1216 0614 0810 0416 1126 1119 0717 0924 0521 ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 220 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Software Not for Customer Distribution NOTES ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 221: Hardware

    Section 10: Hardware Hardware ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 222 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Hardware Not for Customer Distribution NOTES ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 223: Cpu Used With The Aeroset System

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Hardware Not for Customer Distribution CPU Used with the AEROSET System The following table describes units used with the AEROSET System. Memory (RAM) ETM10-AD Pentium 133 MHz 16 MB Pentium MMX 233 MHz 64 MB Celeron 566 MHz...
  • Page 224 PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Hardware Not for Customer Distribution Power Printer Port GPIB Port Receptacle Keyboard Port Monitor Port Host Port Touchscreen Port Figure 12: AEROSET CPU, Rear View (566 MHz) ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 225: Cuvettes

    • Maximum volume of cuvette = 360 µL Cuvette Warranty 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”...

  • Page 226: Gpib

    GPIB is the acronym for General Purpose Interface Bus. ICT™ Warranty Information The ICT module is warranted for whichever occurs first: • A period of two months after installation on the AEROSET System, or • 15,000 ICT samples, or •...

  • Page 227: Observed Problems-Hardware

    Replace the sample arm tubing. Pressure sensor tubing is loose or Reseat or replace the pressure sensor tubing. crimped. Pressure sensor is defective. Contact your Abbott Reprepresentative to replace the pressure sensor. Figure 14: Clot Detection Pressure Sensors ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 228 2. Reset error in the Error Log. defective. 3. Cycle power to the analyzer. • Flash memory data are corrupt. 4. Flash memory. • SCC previously configured in 5. Reconfigure SCC to Demo mode. Demo mode and software reloaded. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 229 START UP Procedure was not START UP Procedure. performed. • Ensure water is present in the Reagent Supply Center. • If still unresolved, contact your Abbott Representative. Cuvette wash pump valve failure or Contact your Abbott Representative. crimped tubing. System DI water source is not 1.

  • Page 230: Serial Numbers

    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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 231: Specifications

    * Refer to USP 24/NF19 Monograph <645> “Water Conductivity” if conductivity meter is not temperature compensated, or conductivity value exceeds 2.1 mS/cm at 25°C. NOTE: The above USP specifications are derived from the ASTM Type III Specification. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 232: Verification Procedures/Adjustments/Alignments

    Figure 16: MAINTENANCE UTILITIES Screen, Rxn Area Page 5. Using the Rxn Crsl buttons, rotate the Reaction Carousel to place the empty position in the optics light path. 6. Select Shutter <ON> to open the shutter. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 233 NOTE: If the Gain value is 2.6 AND A/D reading 35,000, or if the 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;...

  • Page 234: Reagent Arm Adjustment

    2. Select the Rgt Area 1 tab. The Rgt Area 1 page displays. 3. Install a clean, empty reagent cartridge in position A1 of the Reagent Supply Center. A-LIne (Outer) A <Adj> Figure 18: MAINTENANCE UTILITIES Screen, Rgt Area 1 Page ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 235 Reagent probe is not Proceed to step 8. centered over the cartridge Reagent probe is centered Proceed to step 16. over the cartridge 8. Select <Adjust> on the right side of the screen. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 236 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 window. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 237: Reagent Carousel Alignment

    5. Select A-Line (Outer) A <Adj>. A-Line (Outer) A <Adj> Figure 19: MAINTENANCE UTILITIES Screen, Rgt Area 1 Page NOTE: Steps 1 through 5 position the empty cartridge in the R1A adjustment position. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 238 Select <OK> on the over the reagent MAINTENANCE UTILITIES cartridge screen then select <OK> on the Home All Robotics dialog window. 13. Select Rgt Arm A Vert Home/Up <Adj>. 14. Repeat steps 4 through 12. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 239: R1A Probe Cuvette Alignment

    2. Select the Rgt Area 1 tab. The Rgt Area 1 page displays. Rgt Arm A Cuv <Adj> Figure 20: MAINTENANCE UTILITIES Screen, Rgt Area 1 Page 3. Select Rgt Arm A Cuv <Adj>. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 240 R1A probe is not centered Proceed to step 6. over the cuvette R1A probe is centered over Proceed to step 9. the cuvette 6. Select <Adjust> on the right side of the screen. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 241 Not for Customer Distribution 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. Clockwise Counterclockwise 8. Select <OK> to save the position.

  • Page 242: R1A Probe Wash Cup Alignment

    WCup <Adj> 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. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 243: November

    R1A probe is not centered Proceed to step 6. over the wash cup R1A probe is centered over Proceed to step 9. the wash cup 6. Select <Adjust> on the right side of the screen. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 244 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.

  • Page 245: Troubleshooting Flowcharts

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

  • Page 247: Abbott Assay-Basic Assay Troubleshooting

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Flowcharts Not for Customer Distribution Abbott Assay—Basic Assay Troubleshooting Proceed to QC OOR? QC OOR Flowchart Customer Text for assay perceive assay on ASSAYS Stop is performing screen green? as expected? Proceed to Illegal Investigate the...

  • Page 248: Assay Characteristics

    • 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? •...
  • Page 249 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 ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 250: Non-Abbott Assay-Basic Assay Troubleshooting

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Flowcharts Not for Customer Distribution Non-Abbott Assay—Basic Assay Troubleshooting Start Accept Recalibrate & Data rerun QC. OK? Proceed to QC prep & Only affected Abbott Assay— QC concern? handling OK? assay? Basic TS Flowchart Prepare Follow...

  • Page 251: Confirmation Of Assay Parameter Settings

    & position screen; may need screen matching & rescan are on Base page to pull in correct the position; reagents configuration. OK? position for reagent present? reagent name/ position Proceed to #2 (next page) ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 252 7. If a non-self (user defined assay file) blank is defined, the specified test must be configured. 8. Multiple Rgt Ctgs option is ON and R2 and/or R2 reagent is empty. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 253: Erratic Results

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Flowcharts Not for Customer Distribution Erratic Results Address any error codes. Refer to specific Troubleshooting in AEROSET System Operations Manual Perform Replace Reagent Multiple All maintenance Perform precision run reagent expired? assays? up to date? maintenance on selected assays.

  • Page 254: Qc Out Of Range

    Prepare fresh Verify proper reagent. Accept data reagent Accept data Rerun QC. handling. OK? Verify calibration. Recalibrate & Check cal rerun QC. values, cal prep, & expiration. OK? Verify system. Correct errors. Service ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 255 Check when source lamp was installed • Ensure all scheduled maintenance is current • Check for damaged probes, drips, or drops • Check cuvette washer performance • Check for instrument leaks, e.g., pumps and syringes ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 256 Not for Customer Distribution • 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 ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 257: Calibration Errors

    QC to QC Stop Service 2. All assays on the same line? Flowchart Flowchart Proceed to #4 (next page) 3. Move to opposite line & recalibrate. OK? Proceed to #5 (next page) ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 258 Open new lot of calibrators & recalibrate. OK? (If already done, Proceed proceed to #6.) Run QC. to QC Flowchart 6. Replace lamp Run QC. & recalibrate. Proceed to QC Stop Service Flowchart ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 259: Ict™ Failed Calibration

    All OK? Stop Remove bubbles Bubbles in calibrator with applicator stick sample cup? & recalibrate. OK? 1 Verify ICT Dil lot number & onboard date. 2 Verify cartridge location. 3 Verify reagent loadlist. ® AEROSET System Troubleshooting Guide 94816-107—November 2004...
  • Page 260 IRef solution bottle IRef cup draining Perform preheater & filling test correctly? Inspect Sample A Clean/replace probe: Bent? Sample A probe Damaged? Build-up? Inspect R1A probe: Bent? Replace R1A Damaged? probe Build-up? Service ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 261: Bubbles In Ict Module Tubing

    Replacement Procedure in Section 9 of the Operations Manual. Bubbles gone? Other Possibilities: ICT aspiration tubing damaged ICT aspiration pump defective IRef solution filter needs to be Service changed Preheater check ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

  • Page 262: Lis/Communication Problems

    PROPRIETARY INFORMATION CONFIDENTIAL MATERIAL Flowcharts Not for Customer Distribution LIS/Communication Problems Cycle power in this order Power issues to establish handshake: Host down/AEROSET or Error Log Power? down/Host up/AEROSET Messages? Attempt Error Log run. Stop Message? Resolved? Troubleshoot per Operations Manual.
  • Page 263 Resolved? "Resume" Host communiction Verify configuration Changes Make changes Run. Stop matches on Host & required? & cycle power Resolved? AEROSET Run debug Evaluate debug; consult LIS support Change to Contact LIS AEROSET Cycle Run. Vendor configuration power Resolved?

  • Page 264: Water Issue

    OK? flow? 3 Cycle power to Resolved? Analyzer 4 Flush lines on START UP screen Contact Flush water Service Stop lines. Resolved? water vendor Air still Stop present? Service ® AEROSET System Troubleshooting Guide 94816-107—November 2004...

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