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  5. Troubleshooting Manual

Abbott AEROSET Troubleshooting Manual

Summary of 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: Revision Status

    Proprietary information confidential material not for customer distribution aeroset ® system troubleshooting guide 3 94816-107—november 2004 revision status document control number(s) revision date section(s) revised pages revised and added 30-0897/r1 9/98 original issue original issue 30-1762/r2 1/...

  • Page 4

    Proprietary information confidential material not for customer distribution 4 aeroset ® system troubleshooting guide 94816-107—november 2004 highlights of changes from previous aeroset system troubleshooting guide (94819-106) note: this section is intended as a guide to highlight major and significa...

  • Page 5

    Proprietary information confidential material not for customer distribution aeroset ® system troubleshooting guide 5 94816-107—november 2004 • some information previously included in the troubleshooting guide was eliminated because it duplicated information that is readily available to customers in ...

  • Page 6

    Proprietary information confidential material not for customer distribution 6 aeroset ® system troubleshooting guide 94816-107—november 2004 • magnesium assay—new assay-specific information added to describe necessary parameter edits when converting units from meq/l to mg/dl. • software section—new ...

  • Page 7: Table Of Contents

    Proprietary information confidential material not for customer distribution aeroset ® system troubleshooting guide 7 94816-107—november 2004 table of contents revision status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 highlights of changes from previous aeroset system ...

  • Page 8

    Proprietary information confidential material not for customer distribution 8 aeroset ® system troubleshooting guide 94816-107—november 2004 calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39 multiconstituent calibrator (mcc), ln 1e65 . . . . . . . . .39 prod...

  • Page 9

    Proprietary information confidential material not for customer distribution aeroset ® system troubleshooting guide 9 94816-107—november 2004 specimen collection and handling . . . . . . . . . . . . . . . . . . . 88 therapeutic drug monitoring (tdm) assays . . . . . . . . . . . . 89 calibration . . ....

  • Page 10

    Proprietary information confidential material not for customer distribution 10 aeroset ® system troubleshooting guide 94816-107—november 2004 barbiturates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110 cross reactivity testing performed on the aeroset system by syva . ....

  • Page 11

    Proprietary information confidential material not for customer distribution aeroset ® system troubleshooting guide 11 94816-107—november 2004 hemoglobin a 1c (multigent ® ) . . . . . . . . . . . . . . . . . . . . 134 reaction diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134 pret...

  • Page 12

    Proprietary information confidential material not for customer distribution 12 aeroset ® system troubleshooting guide 94816-107—november 2004 rheumatoid factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162 standard material recovery . . . . . . . . . . . . . . . . . . . . . .162...

  • Page 13

    Proprietary information confidential material not for customer distribution aeroset ® system troubleshooting guide 13 94816-107—november 2004 result screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 result screen—viewing rerun result . . . . . . . . . . . . 190 reaction graph ...

  • Page 14

    Proprietary information confidential material not for customer distribution 14 aeroset ® system troubleshooting guide 94816-107—november 2004 maintenance utilities screen, sw info page . . . . .210 printer a configuration window . . . . . . . . . . . . . . . . . .210 online (host) configuration dial...

  • Page 15

    Proprietary information confidential material not for customer distribution aeroset ® system troubleshooting guide 15 94816-107—november 2004 troubleshooting flowcharts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245 abbott assay—basic assay troubleshooting . . . . . . . . ...

  • Page 16: Proprietary Statement

    Proprietary information confidential material not for customer distribution 16 aeroset ® system troubleshooting guide 94816-107—november 2004 proprietary statement copyright 1998, 2004, abbott laboratories, abbott park, illinois. All rights reserved. No part of this document may be reproduced, store...

  • Page 17: Trademark Statements

    Proprietary information confidential material not for customer distribution aeroset ® system troubleshooting guide 17 94816-107—november 2004 master table of contents/index disclaimer incremental manual updates may cause the master table of contents or master index page numbering to change. Trademar...

  • Page 18

    Proprietary information confidential material not for customer distribution 18 aeroset ® system troubleshooting guide 94816-107—november 2004 notes.

  • Page 19: Assays/reagents

    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: General Information

    Proprietary information confidential material not for customer distribution aeroset ® system troubleshooting guide 21 94816-107—november 2004 general information assay configuration/installation refer to the most current version of technical bulletin 1018-2003 when installing new assays. Drugs of ab...

  • Page 22

    Proprietary information confidential material assays/reagents not for customer distribution 22 aeroset ® system troubleshooting guide 94816-107—november 2004 qualitative assay configuration use the following instructions to configure a qualitative assay in absorbance mode. 1. Select in the informati...

  • Page 23

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 23 94816-107—november 2004 print options results for the drugs of abuse (doa) assays can be printed using one of the following options: • factor mode—numeric results • f...

  • Page 24

    Proprietary information confidential material assays/reagents not for customer distribution 24 aeroset ® system troubleshooting guide 94816-107—november 2004 4. The outline page is the default view. Figure 1: assay configuration screen, outline page 5. Verify quantitative ranges is selected ( 聺 ). T...

  • Page 25

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 25 94816-107—november 2004 example of factor mode—numeric results printout the barbiturates assay in this example would be reported as positive. Phencyclidine, propoxyph...

  • Page 26

    Proprietary information confidential material assays/reagents not for customer distribution 26 aeroset ® system troubleshooting guide 94816-107—november 2004 factor mode—pos/neg results when the system is configured for qualitative ranges, results print as pos for a value equal to or higher than the...

  • Page 27

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 27 94816-107—november 2004 6. Select the calibration tab to access the calibration page. Figure 4: assay configuration screen, calibration page 7. Verify the factor opti...

  • Page 28

    Proprietary information confidential material assays/reagents not for customer distribution 28 aeroset ® system troubleshooting guide 94816-107—november 2004 example of factor mode—pos/neg results printout the barbiturates assay in this example would be reported as positive. Phencyclidine, propoxyph...

  • Page 29

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 29 94816-107—november 2004 absorbance mode when the system is in absorbance mode, results print as absorbance values. A result equal to or higher than the multi doa cuto...

  • Page 30

    Proprietary information confidential material assays/reagents not for customer distribution 30 aeroset ® system troubleshooting guide 94816-107—november 2004 7. Select the calibration tab to access the calibration page. Figure 6: assay configuration screen, calibration page 8. Select the list box ic...

  • Page 31

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 31 94816-107—november 2004 example of absorbance mode results printout each assay value in this example would be compared to its cutoff calibrator absorbance to determin...

  • Page 32

    Proprietary information confidential material assays/reagents not for customer distribution 32 aeroset ® system troubleshooting guide 94816-107—november 2004 summary of print options the following table summarizes the three print options for the doa assays. Note: for troubleshooting purposes, absorb...

  • Page 33: Biohazardous Waste

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 33 94816-107—november 2004 biohazardous waste both high and low-concentration waste contain reagent and sample and should be considered biohazardous. Studies of the comb...

  • Page 34: Calculated Assay Results

    Proprietary information confidential material assays/reagents not for customer distribution 34 aeroset ® system troubleshooting guide 94816-107—november 2004 calculated assay results recalculating calculated assay results the assays included in a calculated assay must be performed during the same ru...

  • Page 35: Calibration Information

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 35 94816-107—november 2004 calibration information drugs of abuse (doa) assays ethanol the ethanol assay is a quantitative assay and uses the ethanol 0 and 100 calibrato...

  • Page 36

    Proprietary information confidential material assays/reagents not for customer distribution 36 aeroset ® system troubleshooting guide 94816-107—november 2004 if any trends or sudden shifts in value of the verifiers occur, check the assay reagent cartridge for onboard dating and reagent expiration da...

  • Page 37

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 37 94816-107—november 2004 factor the factor option only displays if factor is selected as the calibration mode. This method allows the operator to enter the factor used...

  • Page 38

    Proprietary information confidential material assays/reagents not for customer distribution 38 aeroset ® system troubleshooting guide 94816-107—november 2004 *3-carboxy-4-nitroaniline use cal factor from use cal factor from option only displays if use factor/blank is selected as the calibration mode...

  • Page 39: Calibrators

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 39 94816-107—november 2004 calibrators multiconstituent calibrator (mcc), ln 1e65 customers may observe differences among mcc calibrator lot numbers, within these specif...

  • Page 40

    Proprietary information confidential material assays/reagents not for customer distribution 40 aeroset ® system troubleshooting guide 94816-107—november 2004 carbon dioxide 1e64-02 cal 1: 3 x 5 ml cal 2: 3 x 5 ml co2 digoxin 1e06-02 cal 1: 1 x 4.8 ml cal 2: 1 x 1.8 ml cal 3: 1 x 1.8 ml cal 4: 1 x 1....

  • Page 41

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 41 94816-107—november 2004 phenobarbital 5f54-02 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 pheno prealbumin 6e57-02...

  • Page 42

    Proprietary information confidential material assays/reagents not for customer distribution 42 aeroset ® system troubleshooting guide 94816-107—november 2004 chemical reactions for clinical chemistry assays assay name reaction tips acp α -naphthylphosphate α -napthol + po 4 -3 α -napthol + diazotize...

  • Page 43

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 43 94816-107—november 2004 alt-a l -alanine + α -ketoglutarate pyruvate + l -glutamate pyruvate + nadh l -lactate + nad + ld = lactate dehydrogenase nadh = nicotinamide ...

  • Page 44

    Proprietary information confidential material assays/reagents not for customer distribution 44 aeroset ® system troubleshooting guide 94816-107—november 2004 ast-a l -aspartate + α -ketoglutarate oxaloacetate + l -glutamate oxaloacetate + nadh l -malate + nad + nadh = nicotinamide adenine dinucleoti...

  • Page 45

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 45 94816-107—november 2004 bild (ln 8g63-20) direct (conjugated) bilirubin + 2,4-dichlorophenyl diazonium salt azobilirubin the formation of azobilirubin is measured spe...

  • Page 46

    Proprietary information confidential material assays/reagents not for customer distribution 46 aeroset ® system troubleshooting guide 94816-107—november 2004 carb antibody to carbamazepine (r1) + g-6-pd-carbamazepine (r2) (active) g-6-pd-carbamazepine:antibody complex (inactive) g-6-pd-carbamazepine...

  • Page 47

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 47 94816-107—november 2004 co2 phospho(enol)pyruvate + hco 3 - oxaloacetate + h 2 po 4 - oxaloacetate + nadh + h + malate + nad + pepc = phospho(enol)pyruvate carboxylas...

  • Page 48

    Proprietary information confidential material assays/reagents not for customer distribution 48 aeroset ® system troubleshooting guide 94816-107—november 2004 dbil (ln 7d59) bilirubin biliverdin cap survey results show a 38.2% cv for 16 different chemistry methodologies. The aeroset system produces h...

  • Page 49

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 49 94816-107—november 2004 etoh adh ethyl alcohol + nad nadh + acetaldehyde adh = alcohol dehydrogenase nadh = nicotinamide adenine dinucleotide uses ethanol 0 and 100 m...

  • Page 50

    Proprietary information confidential material assays/reagents not for customer distribution 50 aeroset ® system troubleshooting guide 94816-107—november 2004 hba1c* total hemoglobin: hemoglobin + alkaline non-ionic surfactant hematin (green solution) hemoglobin a 1c : hba 1c + anti-hba 1c antibody:m...

  • Page 51

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 51 94816-107—november 2004 iron fe-transferrin fe +3 + transferrin fe +3 fe +2 fe +2 + ferene fe-ferene complex serum only. Separate from red blood cells as soon after c...

  • Page 52

    Proprietary information confidential material assays/reagents not for customer distribution 52 aeroset ® system troubleshooting guide 94816-107—november 2004 ldl* hdl, ldl, vldl, chylomicrons ldl (non-ldl particles consumed in a non-color forming reaction) ldl cholesterol cholesterone + h 2 o 2 h 2 ...

  • Page 53

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 53 94816-107—november 2004 mg arsenazo iii + mg +2 mg-arsenazo iii complex perform calibration with each reagent cartridge used. 24 hour calibration requirement due to o...

  • Page 54

    Proprietary information confidential material assays/reagents not for customer distribution 54 aeroset ® system troubleshooting guide 94816-107—november 2004 pcp antibody to phencyclidine (r1) + g-6-pd-phencyclidine (r2) (active) g-6-pd-phencyclidine:antibody complex (inactive) g-6-pd-phencyclidine:...

  • Page 55

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 55 94816-107—november 2004 prpx antibody to propoxyphene (r1) + g-6-pd-propoxyphene (r2) (active) g-6-pd-propoxyphene:antibody complex (inactive) g-6-pd-propoxyphene:ant...

  • Page 56

    Proprietary information confidential material assays/reagents not for customer distribution 56 aeroset ® system troubleshooting guide 94816-107—november 2004 thc50 antibody to thc (r1) + g-6-pd-thc (r2) (active) g-6-pd-thc:antibody complex (inactive) g-6-pd-thc:antibody complex (inactive) + uc g-6-p...

  • Page 57

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 57 94816-107—november 2004 theo antibody to theophylline (r1) + g-6-pd-theophylline (r2) (active) g-6-pd-theophylline:antibody complex (inactive) g-6-pd-theophylline:ant...

  • Page 58

    Proprietary information confidential material assays/reagents not for customer distribution 58 aeroset ® system troubleshooting guide 94816-107—november 2004 trf transferrin + peg/buffer (r1) + antibody to transferrin (r2) turbidity due to transferrin:antibody complex peg = polyethylene glycol trig ...

  • Page 59

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 59 94816-107—november 2004 uric uric acid + o 2 + h 2 o allantoin + co 2 + h 2 o 2 2h 2 o 2 + 4-aap + tbhb quinoneimine + h 2 o tbhb = 2,4,6 tribromo-3-hydroxy benzoic a...

  • Page 60: Drugs of Abuse (Doa) Assays

    Proprietary information confidential material assays/reagents not for customer distribution 60 aeroset ® system troubleshooting guide 94816-107—november 2004 drugs of abuse (doa) assays assay details trade/alternate name street name physical description major compounds/ metabolites amphetamine/ meth...

  • Page 61

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 61 94816-107—november 2004 methadone dolophine, amidone methadose tablets methadone (eddp) and metabolites opiates heroin: diacetylmorphine morphine: duramorph, oramorph...

  • Page 62

    Proprietary information confidential material assays/reagents not for customer distribution 62 aeroset ® system troubleshooting guide 94816-107—november 2004 assay details (continued) use normal detection time in urine symptoms of abuse possible dangers amphetamine/ methamphetamine taken orally, inj...

  • Page 63

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 63 94816-107—november 2004 cocaine • free base: vaporized then smoked • white power: intravenously, nasal insuffulation (“snorting” or “sniffing”) 2 to 3 days extreme eu...

  • Page 64

    Proprietary information confidential material assays/reagents not for customer distribution 64 aeroset ® system troubleshooting guide 94816-107—november 2004 opiates intravenously, orally • heroin: rapidly metabolizes to morphine, 72 hours • morphine: 3 days • other: 2 to 4 days • acute: abnormal se...

  • Page 65

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 65 94816-107—november 2004 cross reactivity refer to assay-specific information in this section for additional assay-specific cross reactivity information. Each doa assa...

  • Page 66: Multigent

    Proprietary information confidential material assays/reagents not for customer distribution 66 aeroset ® system troubleshooting guide 94816-107—november 2004 multigent ® assays general information multigent assays are supplied to abbott from original equipment manufacturers (oem) and include abbott ...

  • Page 67

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 67 94816-107—november 2004 plasma claims for gel barrier tubes for assays that allow plasma as a suitable specimen, the following statement appears in the package insert...

  • Page 68: Proficiency Testing

    Proprietary information confidential material assays/reagents not for customer distribution 68 aeroset ® system troubleshooting guide 94816-107—november 2004 proficiency testing aab reagent codes analyte code methodology albumin bcg 130 abbott bromcresol green albumin bcp 146 abbott bromcresol purpl...

  • Page 69

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 69 94816-107—november 2004 cap codes serum survey analyte cap code methodology acid phosphatase 1518 abbott/37°c albumin bcg 1099 bromcresol green/dye binding albumin bc...

  • Page 70

    Proprietary information confidential material assays/reagents not for customer distribution 70 aeroset ® system troubleshooting guide 94816-107—november 2004 hemoglobin a 1c * 1055 abbott aeroset hdl, direct 1757 liquid selective detergent (enzymatic) iron 1207 ferene without a protein removal step ...

  • Page 71

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 71 94816-107—november 2004 urine survey csf survey immunology analyte cap code methodology amylase 1518 abbott/37°c calcium 1138 arsenazo iii dye chloride 1227 ion-selec...

  • Page 72

    Proprietary information confidential material assays/reagents not for customer distribution 72 aeroset ® system troubleshooting guide 94816-107—november 2004 therapeutic drug monitoring urine drug testing (drugs of abuse) analyte cap code methodology carbamazepine 3254 abbott aeroset digoxin* 3254 a...

  • Page 73: Quality Control

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 73 94816-107—november 2004 quality control bio-rad control products note: information in tables is subject to change; refer to vendor for latest information control prod...

  • Page 74

    Proprietary information confidential material assays/reagents not for customer distribution 74 aeroset ® system troubleshooting guide 94816-107—november 2004 liquichek pediatric control l-1: 354 l-2: 355 6 x 4 ml 6 x 4 ml bild biln bilt ca cl glu k mg na theo liquichek ethanol/ammonia control l-1: 5...

  • Page 75

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 75 94816-107—november 2004 liquichek qualitative urine toxicology control negative: 454 positive: 455 6 x 3 ml 6 x 3 ml ampm barb benz coc etoh meth pcp prpx thc liquich...

  • Page 76

    Proprietary information confidential material assays/reagents not for customer distribution 76 aeroset ® system troubleshooting guide 94816-107—november 2004 ordering information commercial controls are available from several vendors. Note: analyte concentrations in commercial controls can vary from...

  • Page 77

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 77 94816-107—november 2004 establishing quality control limits use the following instructions to establish quality control limits for abbott clinical chemistry assays. T...

  • Page 78

    Proprietary information confidential material assays/reagents not for customer distribution 78 aeroset ® system troubleshooting guide 94816-107—november 2004 d. After calibration, if any control is not within its control limits, check control, calibrator, and reagent handling, then rerun the control...

  • Page 79

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 79 94816-107—november 2004 temporary control limits worksheet assay name:_______________________________________________ lot#: _______________________ exp. Date: _______...

  • Page 80: Reagent Test Count Tracking

    Proprietary information confidential material assays/reagents not for customer distribution 80 aeroset ® system troubleshooting guide 94816-107—november 2004 reagent test count tracking reagent test counts the aeroset system performs a level sense in the reagent cartridge and calculates the remainin...

  • Page 81: Sample Blanking

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 81 94816-107—november 2004 sample blanking self blank vs. Non-self blank self blank the blank is done in the same cuvette as assay measurement. It is typically done with...

  • Page 82: Sample Interference Indices

    Proprietary information confidential material assays/reagents not for customer distribution 82 aeroset ® system troubleshooting guide 94816-107—november 2004 sample interference indices the sample interference indices protocol is available on the aeroset assay disk, assays > 50 (ln 2k15 and 2k16). T...

  • Page 83: Smartwash™

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 83 94816-107—november 2004 smartwash™ smartwash (reagent carryover) when moving a and b-line assays when the aeroset assay/configuration disks are loaded, a and b-line d...

  • Page 84

    Proprietary information confidential material assays/reagents not for customer distribution 84 aeroset ® system troubleshooting guide 94816-107—november 2004 smartwash™ parameters when a smartwash is configured for the reagent probe, the aeroset system attempts to schedule the assay so the two assay...

  • Page 85: Specific Proteins Assays

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 85 94816-107—november 2004 specific proteins assays the abbott clinical chemistry specific proteins menu includes apolipoprotein a1 and b; complement c3 and c4; haptoglo...

  • Page 86

    Proprietary information confidential material assays/reagents not for customer distribution 86 aeroset ® system troubleshooting guide 94816-107—november 2004 ) frequently asked questions (faq) question response why are linearity claims only up to the highest calibrator? • non-linear assays (c3, c4, ...

  • Page 87

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 87 94816-107—november 2004 when a manual dilution is performed for the iga and igm assays, what value should be entered for the sample dilution? Enter the manual dilutio...

  • Page 88

    Proprietary information confidential material assays/reagents not for customer distribution 88 aeroset ® system troubleshooting guide 94816-107—november 2004 specimen collection and handling in the specimen collection and handling section of the package inserts, many state: “separate from red blood ...

  • Page 89

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 89 94816-107—november 2004 therapeutic drug monitoring (tdm) assays the abbott clinical chemistry therapeutic drug monitoring (tdm) menu includes carbamazepine, phenobar...

  • Page 90

    Proprietary information confidential material assays/reagents not for customer distribution 90 aeroset ® system troubleshooting guide 94816-107—november 2004 frequently asked questions (faq) question response why are phenytoin precision data from only two instruments included in the package insert? ...

  • Page 91

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 91 94816-107—november 2004 why is phenytoin compared to high-performance liquid chromatography (hplc) methodology, but not the other tdm assays? Hplc is commonly conside...

  • Page 92: Verification Procedures

    Proprietary information confidential material assays/reagents not for customer distribution 92 aeroset ® system troubleshooting guide 94816-107—november 2004 verification procedures confirming the limit of detection (lod) the limit of detection (lod) represents the noise associated with the analytic...

  • Page 93

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 93 94816-107—november 2004 procedure 1. Prepare one blank level for each assay to be tested. 2. Select database > in the information access area of the main display. The...

  • Page 94

    Proprietary information confidential material assays/reagents not for customer distribution 94 aeroset ® system troubleshooting guide 94816-107—november 2004 limit of detection for abbott assays data sheet date: _____________ analyte: ___________________________________________________________ instr...

  • Page 95

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 95 94816-107—november 2004 limit of detection for abbott assays data sheet example date: 3/11/03 analyte: abc instrument: aeroset system serial no.: 1243 record the valu...

  • Page 96

    Proprietary information confidential material assays/reagents not for customer distribution 96 aeroset ® system troubleshooting guide 94816-107—november 2004 confirming the limit of quantitation (loq) the limit of quantitation (loq) represents the analyte concentration corresponding to a coefficient...

  • Page 97

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting 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...

  • Page 98

    Proprietary information confidential material assays/reagents not for customer distribution 98 aeroset ® system troubleshooting guide 94816-107—november 2004 limit of quantitation for abbott assays data sheet date: _____________ analyte: ___________________________________________________________ in...

  • Page 99

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 99 94816-107—november 2004 limit of quantitation for abbott assays data sheet example date: 3/11/03 analyte: abc instrument: aeroset system serial no.: 1243 record the v...

  • Page 100

    Proprietary information confidential material assays/reagents not for customer distribution 100 aeroset ® system troubleshooting guide 94816-107—november 2004 notes.

  • Page 101: Assay-Specific Information

    Proprietary information confidential material not for customer distribution aeroset ® system troubleshooting guide 101 94816-107—november 2004 assay-specific information acid phosphatase method comparison the abbott clinical chemistry acid phosphatase (acp) assay compares well to some other assays a...

  • Page 102

    Proprietary information confidential material assays/reagents not for customer distribution 102 aeroset ® system troubleshooting guide 94816-107—november 2004 although paramax and aeroset assays definitely correlate (as shown by the r value), a specimen tested on the aeroset will yield a value appro...

  • Page 103: Albumin Bcg

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 103 94816-107—november 2004 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 sys...

  • Page 104: Alt

    Proprietary information confidential material assays/reagents not for customer distribution 104 aeroset ® system troubleshooting guide 94816-107—november 2004 alt ammonium heparin tube not acceptable ammonium heparin was removed from the list of approved anticoagulants for alt, alt-a, ast, and ast-a...

  • Page 105: Amphetamine/methamphetamine

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 105 94816-107—november 2004 amphetamine/methamphetamine cross reactivity testing performed on the aeroset system by syva compounds listed in the following table yielded ...

  • Page 106: Amylase

    Proprietary information confidential material assays/reagents not for customer distribution 106 aeroset ® system troubleshooting guide 94816-107—november 2004 amylase interference information icodextrin, a complex carbohydrate contained in some fluids used for peritoneal dialysis, has been reported ...

  • Page 107: Apolipoprotein A1

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 107 94816-107—november 2004 apolipoprotein a1 observed problems falsely lowered results near the concentration of cal 1 probable cause(s) corrective action(s) apo al/apo...

  • Page 108: Apolipoprotein B

    Proprietary information confidential material assays/reagents not for customer distribution 108 aeroset ® system troubleshooting guide 94816-107—november 2004 apolipoprotein b observed problems falsely lowered results near the concentration of cal 1 probable cause(s) corrective action(s) apo al/apo ...

  • Page 109: Ast

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 109 94816-107—november 2004 ast ammonium heparin tube not acceptable refer to alt in this section for details. Ast activated ammonium heparin tube not acceptable refer t...

  • Page 110: Barbiturates

    Proprietary information confidential material assays/reagents not for customer distribution 110 aeroset ® system troubleshooting guide 94816-107—november 2004 barbiturates cross reactivity testing performed on the aeroset system by syva compounds listed in the following table yielded a negative resu...

  • Page 111

    Proprietary information confidential material not for customer 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 ...

  • Page 112: Benzodiazepines

    Proprietary information confidential material assays/reagents not for customer distribution 112 aeroset ® system troubleshooting guide 94816-107—november 2004 benzodiazepines cross reactivity testing performed on the aeroset system by syva compounds listed in the following table yielded a result app...

  • Page 113

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 113 94816-107—november 2004 fluoxetine 500 glutethimide 500 ketamine 100 ketorolac tromethamine 1,000 lysergic acid diethylamide (lsd) 10 ng/ml meperidine 1,000 nortript...

  • Page 114: Calcium

    Proprietary information confidential material assays/reagents not for customer distribution 114 aeroset ® system troubleshooting guide 94816-107—november 2004 calcium observed problem lod/loq claim not duplicated by customer probable cause(s) corrective action(s) reagent cross contamination. Note: c...

  • Page 115: Cannabinoids

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 115 94816-107—november 2004 cannabinoids cross reactivity testing performed on the aeroset system by syva compounds listed in the following table yielded a negative resu...

  • Page 116

    Proprietary information confidential material assays/reagents not for customer distribution 116 aeroset ® system troubleshooting guide 94816-107—november 2004 troubleshooting imprecision imprecision on the cannabinoids assay can be the result of: • crimped tubing, especially at the cuvette wash stat...

  • Page 117: Cocaine

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 117 94816-107—november 2004 cocaine cross reactivity testing performed on the aeroset system by syva compounds listed in the following table yielded a negative result at...

  • Page 118

    Proprietary information confidential material assays/reagents not for customer 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 s...

  • Page 119: Complement C3

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 119 94816-107—november 2004 complement c3 observed problems lh result error code observed when result is less than the highest calibrator probable cause(s) corrective ac...

  • Page 120: Complement C4

    Proprietary information confidential material assays/reagents not for customer distribution 120 aeroset ® system troubleshooting guide 94816-107—november 2004 complement c4 observed problems lh result error code observed when result is less than the highest calibrator probable cause(s) corrective ac...

  • Page 121: C-Reactive Protein

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 121 94816-107—november 2004 c-reactive protein before troubleshooting the crp assay, ensure the assay parameters were configured correctly. Do not install the crp assay ...

  • Page 122

    Proprietary information confidential material assays/reagents not for customer distribution 122 aeroset ® system troubleshooting guide 94816-107—november 2004 the crp r2 reagent contains latex microparticles. Is inversion of r2 reagent required before every run to ensure the particles do not settle?...

  • Page 123

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 123 94816-107—november 2004 is the assay number for the new crp assay the same as the original crp assay? Yes. However, this it not an issue because the “original” crp a...

  • Page 124

    Proprietary information confidential material assays/reagents not for customer distribution 124 aeroset ® system troubleshooting guide 94816-107—november 2004 as the lamp ages and performance diminishes, should we assume that results will increase for this assay? Logically, less lamp intensity would...

  • Page 125: Creatine Kinase

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 125 94816-107—november 2004 creatine kinase flexrate™ linearity is not stated in the linearity section of the ck package insert; however, flex read times (22 – 25) and a...

  • Page 126

    Proprietary information confidential material assays/reagents not for customer distribution 126 aeroset ® system troubleshooting guide 94816-107—november 2004 cross reactivity the following digoxin cross reactivity data are not included in the package insert. Note: test results were obtained with an...

  • Page 127

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 127 94816-107—november 2004 sample carryover no sample carryover effects were observed when testing samples with high digoxin concentration (4.0 to 5.0 ng/ml) immediatel...

  • Page 128: Direct Ldl (Multigent

    Proprietary information confidential material assays/reagents not for customer distribution 128 aeroset ® system troubleshooting guide 94816-107—november 2004 direct ldl (multigent ® ) sample storage and stability • samples should not be frozen at -20°c. • samples stored at -25°c for 1 month showed ...

  • Page 129

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 129 94816-107—november 2004 linearity verifiers (80-5953-00, 2 x 3 ml) the linearity verifiers are genzyme products and should be ordered from genzyme. Verifiers are sta...

  • Page 130

    Proprietary information confidential material assays/reagents not for customer distribution 130 aeroset ® system troubleshooting 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%...

  • Page 131

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 131 94816-107—november 2004 observed problem frequently asked questions (faq) question/comment response multigent ® direct ldl does not match the friedewald (calculated)...

  • Page 132: Ethanol

    Proprietary information confidential material assays/reagents not for customer distribution 132 aeroset ® system troubleshooting guide 94816-107—november 2004 ethanol specificity ethanol (ethyl alcohol) specificity was tested by conducting studies on specific compounds; refer to the package insert f...

  • Page 133: Haptoglobin

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 133 94816-107—november 2004 haptoglobin observed problem lh result error code observed when result is less than the highest calibrator probable cause(s) corrective actio...

  • Page 134: Hemoglobin A

    Proprietary information confidential material assays/reagents not for customer distribution 134 aeroset ® system troubleshooting guide 94816-107—november 2004 hemoglobin a 1c (multigent ® ) reaction diagram step 1 step 2 hemoglobin a 1c concentration is inversely proportional to absorbance change. H...

  • Page 135

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 135 94816-107—november 2004 pretreatment (hemolysate preparation) 1. Using a calibrated positive displacement micropipette, dispense 400 µl hemoglobin denaturant into a ...

  • Page 136

    Proprietary information confidential material assays/reagents not for customer distribution 136 aeroset ® system troubleshooting guide 94816-107—november 2004 accuracy by recovery of standards six midpoint samples were prepared by mixing 1:1 proportions of each calibrator with the next highest calib...

  • Page 137

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 137 94816-107—november 2004 hemoglobin denaturant storage conditions the recommended storage temperature for the hemoglobin denaturant is 2 to 8°c. A study was performed...

  • Page 138

    Proprietary information confidential material assays/reagents not for customer distribution 138 aeroset ® system troubleshooting guide 94816-107—november 2004 pipet mix 1. 400 µl denaturant was added to plastic tubes. 2. Blood sample was pipetted by rinsing the tip once with blood. 3. The pipet tip ...

  • Page 139

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 139 94816-107—november 2004 interference information any condition that shortens rbc survival, e.G. , hemolytic anemia or hemolytic diseases, pregnancy, and recent signi...

  • Page 140

    Proprietary information confidential material assays/reagents not for customer distribution 140 aeroset ® system troubleshooting 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 unimat...

  • Page 141

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 141 94816-107—november 2004 frequently asked questions (faq) question response multigent ® hemoglobin a 1c results do not match another method. Why? Multigent hemoglobin...

  • Page 142

    Proprietary information confidential material assays/reagents not for customer distribution 142 aeroset ® system troubleshooting guide 94816-107—november 2004 the reaction mode for hba 1c is listed as rate up in the package insert. Why does the reaction graph appear to show an end down reaction? • t...

  • Page 143: Ict™

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 143 94816-107—november 2004 ict™ l and h (reference range) result flags display with no result when error log message 351 or 352 is generated when the error log message ...

  • Page 144: Immunoglobulin A

    Proprietary information confidential material assays/reagents not for customer distribution 144 aeroset ® system troubleshooting guide 94816-107—november 2004 immunoglobulin a observed problems assay button text is black probable cause(s) corrective action(s) diluent not loaded and/or configured in ...

  • Page 145: Immunoglobulin G

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 145 94816-107—november 2004 immunoglobulin g observed problems lh result error code observed when result is less than the highest calibrator probable cause(s) corrective...

  • Page 146: Immunoglobulin M

    Proprietary information confidential material assays/reagents not for customer distribution 146 aeroset ® system troubleshooting guide 94816-107—november 2004 immunoglobulin m observed problems assay button text is black probable cause(s) corrective action(s) diluent not loaded and/or configured in ...

  • Page 147

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® 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 o...

  • Page 148: Iron

    Proprietary information confidential material assays/reagents not for customer distribution 148 aeroset ® system troubleshooting guide 94816-107—november 2004 iron interference information desferal is the brand name for deferoxamine mesylate or desferoxamine; it is an iron chelating substance indica...

  • Page 149: Magnesium

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 149 94816-107—november 2004 magnesium units conversion current assay configuration settings for the magnesium assay provide meq/l as conventional units and mmol/l as int...

  • Page 150

    Proprietary information confidential material assays/reagents not for customer distribution 150 aeroset ® system troubleshooting guide 94816-107—november 2004 perform the following steps to convert magnesium results from meq/l to mg/dl. 1. Multiply existing values by the conversion factor, 1.215. 2....

  • Page 151: Methadone

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 151 94816-107—november 2004 methadone cross reactivity testing performed on the aeroset system by syva compounds listed in the following table yielded a negative result ...

  • Page 152: Microalbumin (Multigent

    Proprietary information confidential material assays/reagents not for customer distribution 152 aeroset ® system troubleshooting guide 94816-107—november 2004 microalbumin (multigent ® ) specimen storage if specimens cannot be analyzed immediately, they should be stored observing the following guide...

  • Page 153: Opiates 300

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 153 94816-107—november 2004 opiates 300 cross reactivity testing performed on the aeroset system by syva compounds listed in the following table yielded a negative resul...

  • Page 154

    Proprietary information confidential material assays/reagents not for customer distribution 154 aeroset ® system troubleshooting guide 94816-107—november 2004 note: therapeutic doses of ofloxacin (floxin) or levofloxacin (levaquin), non-opiates, may produce positive results with this assay. A positi...

  • Page 155: Opiates 2,000

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 155 94816-107—november 2004 opiates 2,000 cross reactivity testing performed on the aeroset system by syva compounds listed in the following table below yielded a negati...

  • Page 156

    Proprietary information confidential material assays/reagents not for customer distribution 156 aeroset ® system troubleshooting guide 94816-107—november 2004 note: therapeutic doses of ofloxacin (floxin) or levofloxacin (levaquin), non-opiates, may produce positive results with this assay. A positi...

  • Page 157: Phencyclidine

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 157 94816-107—november 2004 phencyclidine cross reactivity testing performed on the aeroset system by syva compounds listed in the following table yielded a negative res...

  • Page 158

    Proprietary information confidential 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: Prealbumin

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 159 94816-107—november 2004 prealbumin observed problems lh result error code observed when result is less than the highest calibrator probable cause(s) corrective actio...

  • Page 160: Propoxyphene

    Proprietary information confidential material assays/reagents not for customer distribution 160 aeroset ® system troubleshooting guide 94816-107—november 2004 propoxyphene cross reactivity testing performed on the aeroset system by syva compounds listed in the following table yielded a negative resu...

  • Page 161

    Proprietary information 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: Rheumatoid Factor

    Proprietary information confidential material assays/reagents not for customer distribution 162 aeroset ® system troubleshooting guide 94816-107—november 2004 rheumatoid factor before troubleshooting the rf assay, ensure the assay parameters were configured correctly. Do not install the rf assay usi...

  • Page 163

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 163 94816-107—november 2004 frequently asked questions (faq) question response how much shift is observed for the rf bio-rad liquichek control toward the end of shelf li...

  • Page 164

    Proprietary information confidential material assays/reagents not for customer distribution 164 aeroset ® system troubleshooting guide 94816-107—november 2004 were plasma specimens evaluated for use with the rf assay? Yes. Initially, it was the project development team’s goal to develop a plasma cla...

  • Page 165

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 165 94816-107—november 2004 during rf precision studies on the aeroset and c 8000 ® , how many points were below the loq of 10, and excluded for the level 1 control? Non...

  • Page 166

    Proprietary information confidential material assays/reagents not for customer distribution 166 aeroset ® system troubleshooting guide 94816-107—november 2004 why does the rf assay have a reaction check programmed but the crp assay does not? The shape of the rf progress curve allows for use of the r...

  • Page 167: Total Bilirubin

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 167 94816-107—november 2004 total bilirubin observed problem total protein interference information dextran has been reported to negatively interfere with the abbott cli...

  • Page 168: Transferrin

    Proprietary information confidential material assays/reagents not for customer distribution 168 aeroset ® system troubleshooting guide 94816-107—november 2004 transferrin observed problems lh result error code observed when result is less than the highest calibrator probable cause(s) corrective acti...

  • Page 169: Valproic Acid (Multigent

    Proprietary information confidential material not for customer distribution assays/reagents aeroset ® system troubleshooting guide 169 94816-107—november 2004 valproic acid (multigent ® ) accuracy by recovery five midpoint samples were prepared by mixing 1:1 proportions of each calibrator with the n...

  • Page 170

    Proprietary information confidential material assays/reagents not for customer distribution 170 aeroset ® system troubleshooting guide 94816-107—november 2004 frequently asked questions (faq) question response multigent ® valproic acid results do not match another method. Why? Multigent valproic aci...

  • Page 171: Software

    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

    Proprietary information confidential material not for customer distribution software aeroset ® system troubleshooting guide 173 94816-107—november 2004 color coding on the aeroset system assay ok (green) reagent low/ cal error (yellow) reagent expired or empty/ calibration expired or unusable (pink)...

  • Page 174: Exporting Files

    Proprietary information confidential material software not for customer distribution 174 aeroset ® system troubleshooting guide 94816-107—november 2004 exporting files exported data a change was made to the name of the folder to which data are exported. In software v1.00er005 and v1.00er005.2, the f...

  • Page 175: Host Interface Trace Log

    Proprietary information confidential material not for customer distribution software aeroset ® system troubleshooting guide 175 94816-107—november 2004 host interface trace log when transmission errors occur, the system generates an error log message. The message in the display area no longer appear...

  • Page 176: Observed Problems—Software

    Proprietary information confidential material software not for customer distribution 176 aeroset ® system troubleshooting guide 94816-107—november 2004 observed problems—software = auto rerun is not performed on replicate samples probable cause(s) corrective action(s) system functionality. Manually ...

  • Page 177

    Proprietary information confidential material not for customer distribution software aeroset ® system troubleshooting guide 177 94816-107—november 2004 is selected on the select assays for stat screen to begin a run, but the run is not initiated; system status is run probable cause(s) corrective act...

  • Page 178: Quality Control

    Proprietary information confidential material software not for customer distribution 178 aeroset ® system troubleshooting guide 94816-107—november 2004 quality control interval qc interval qc is not based on the actual number of samples for an assay, but is based on the number of samples aspirated o...

  • Page 179

    Proprietary information confidential material not for customer distribution software aeroset ® system troubleshooting guide 179 94816-107—november 2004 qc statistics—decimal places the decimal places used for qc statistics are based on the value configured in the decimal places field on the base pag...

  • Page 180: Rounding of Numbers

    Proprietary information confidential material software not for customer distribution 180 aeroset ® system troubleshooting guide 94816-107—november 2004 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 u...

  • Page 181: Screen Hierarchy

    Proprietary information confidential material not for customer distribution software aeroset ® system troubleshooting guide 181 94816-107—november 2004 screen hierarchy action area of the main displa y run options select assays for stat start up options shutdown options error log host communication ...

  • Page 182

    Proprietary information confidential material software not for customer distribution 182 aeroset ® system troubleshooting guide 94816-107—november 2004 inf o rmation access area of the main displa y order print assays del prev result print options page setup order samples lj graph assay status resul...

  • Page 183: Screen Navigation

    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

    Proprietary information confidential material software not for customer 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 ...

  • Page 185

    Proprietary 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

    Proprietary 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

    Proprietary information confidential material not for customer distribution software aeroset ® system troubleshooting guide 189 94816-107—november 2004 form 2 report on-line data transfer dialog window 5/21/98 13:10 instrument #: 0001 address 1 address 2 address 3 address 4 address 5 sample id: age:...

  • 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

    Proprietary 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

    Proprietary information confidential 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

    Proprietary 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

    Proprietary 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

    Proprietary 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

    Proprietary information 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

    Proprietary information confidential 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

    Proprietary information 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

    Proprietary information confidential material software 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 us...

  • 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

    Proprietary information 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

    Proprietary information confidential 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

    Proprietary information confidential 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

    Proprietary information 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

    Proprietary 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

    Proprietary information confidential 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

    Proprietary information confidential material not for customer distribution software aeroset ® system 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...

  • Page 212: System Configuration

    Proprietary information confidential material software not for customer distribution 212 aeroset ® system troubleshooting guide 94816-107—november 2004 system configuration fac limit % field—configuration the fac limit % field was added to the calibration page of the assay configuration screen with ...

  • Page 213

    Proprietary information confidential material not for customer distribution software aeroset ® system troubleshooting guide 213 94816-107—november 2004 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 v...

  • Page 214

    Proprietary information confidential material software not for customer distribution 214 aeroset ® system troubleshooting guide 94816-107—november 2004 5. For the unit configuration screen only: select on the save parameters confirmation dialog window to return to the c:\ prompt. 6. Type exit then p...

  • Page 215

    Proprietary information confidential material not for customer distribution software aeroset ® system troubleshooting guide 215 94816-107—november 2004 unit configuration default screen the default view of the aeroset software v1.02er000 unit configuration screen is shown below. Also included is a t...

  • Page 216

    Proprietary information confidential material software not for customer distribution 216 aeroset ® system troubleshooting guide 94816-107—november 2004 * customer defined at v1.02er000 installation. Refer to the installation configuration questionnaire included in the most recent revision of tsb 125...

  • Page 217

    Proprietary information confidential material not for customer distribution software aeroset ® system troubleshooting guide 217 94816-107—november 2004 startup/shutdown setting default screens default views of the aeroset software v1.02er000 automatic startup/shutdown setting screen are shown below....

  • Page 218

    Proprietary information confidential material software not for customer distribution 218 aeroset ® system troubleshooting guide 94816-107—november 2004 figure 11: startup/shutdown (shutdown-1) setting screen, default view automatic shutdown options option shutdown-1 shutdown-2 shutdown-3 change bath...

  • Page 219: User Codes/passwords

    Proprietary information confidential material not for customer distribution software aeroset ® system troubleshooting guide 219 94816-107—november 2004 user codes/passwords a new user code/password was created to give customers access to “extra” level functions. The password changes daily, so the cu...

  • Page 220

    Proprietary information confidential material software not for customer distribution 220 aeroset ® system troubleshooting guide 94816-107—november 2004 notes.

  • Page 221: Hardware

    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

    Proprietary information confidential material not for customer distribution hardware aeroset ® system troubleshooting guide 223 94816-107—november 2004 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)...

  • Page 224

    Proprietary information confidential material 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: Cuvettes

    Proprietary information confidential material not for customer distribution hardware aeroset ® system troubleshooting guide 225 94816-107—november 2004 cuvettes cuvette volumes—minimum and maximum volumes (min and max) for the reaction cuvettes: • minimum volume in cuvette to achieve adequate mixing...

  • Page 226: Gpib

    Proprietary information confidential material hardware not for customer distribution 226 aeroset ® system troubleshooting guide 94816-107—november 2004 gpib gpib is the acronym for general purpose interface bus. Ict™ warranty information the ict module is warranted for whichever occurs first: • a pe...

  • Page 227: Observed Problems—Hardware

    Proprietary information confidential material not for customer distribution hardware aeroset ® system troubleshooting guide 227 94816-107—november 2004 observed problems—hardware figure 14: clot detection pressure sensors erroneous error log messages related to the clot detection system: 341 invalid...

  • Page 228

    Proprietary information confidential material hardware not for customer distribution 228 aeroset ® system troubleshooting guide 94816-107—november 2004 figure 15: clot detection pressure sensors (close-up) fatal error: gpib error log message x (x equals 1 through 11) probable cause(s) corrective act...

  • Page 229

    Proprietary information confidential material not for customer distribution hardware aeroset ® system troubleshooting guide 229 94816-107—november 2004 reagent supply centers have no water probable cause(s) corrective action(s) water evaporated. Ensure reagent supply center covers are securely in pl...

  • Page 230: Serial Numbers

    Proprietary information confidential material hardware not for customer distribution 230 aeroset ® system troubleshooting guide 94816-107—november 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 = janua...

  • Page 231: Specifications

    Proprietary information confidential material not for customer distribution hardware aeroset ® system troubleshooting guide 231 94816-107—november 2004 specifications water usp purified and wfi requirements purified water water for injection conductivity not greater than 2.1 ms/cm at 25°c* not great...

  • Page 232

    Proprietary information confidential material hardware not for customer distribution 232 aeroset ® system troubleshooting guide 94816-107—november 2004 verification procedures/adjustments/alignments lamp gain and a/d check perform the following procedure to check lamp gains and a/d reads. This will ...

  • Page 233

    Proprietary information confidential material not for customer distribution hardware aeroset ® system troubleshooting guide 233 94816-107—november 2004 7. Select . The photometer and ict™ a/d data screen displays. Figure 17: photometer and ict a/d data screen 8. Observe the displayed gain and a/d va...

  • Page 234

    Proprietary information confidential material hardware not for customer distribution 234 aeroset ® system troubleshooting guide 94816-107—november 2004 reagent arm adjustment note: ensure the reagent probe is not bent or damaged before performing any of the following adjustment procedures. Note: the...

  • Page 235

    Proprietary information confidential material not for customer distribution hardware aeroset ® system troubleshooting guide 235 94816-107—november 2004 4. Select a-line (outer) a > to position the empty cartridge in the r1a adjustment position. 5. Select rgt arm a horz rgt . Caution: the r1a reagent...

  • Page 236

    Proprietary information confidential material hardware not for customer distribution 236 aeroset ® system troubleshooting guide 94816-107—november 2004 9. Select cw > (clockwise) or ccw > (counterclockwise) as needed to center the probe over the reagent cartridge. 10. When the probe is centered, sel...

  • Page 237

    Proprietary information confidential material not for customer distribution hardware aeroset ® system troubleshooting guide 237 94816-107—november 2004 reagent carousel alignment note: this procedure is performed after r1a probe horizontal adjustment . 1. Install a clean, empty reagent cartridge in ...

  • Page 238

    Proprietary information confidential material hardware not for customer distribution 238 aeroset ® system troubleshooting guide 94816-107—november 2004 6. Verify reagent probe alignment over the reagent cartridge. 7. Select on the right side of the screen. 8. Select cw > (clockwise) or ccw > (counte...

  • Page 239

    Proprietary information confidential material not for customer distribution hardware aeroset ® system troubleshooting guide 239 94816-107—november 2004 r1a probe cuvette alignment 1. Select the maintenance utilities icon in the action area of the main display. The maintenance utilities screen displa...

  • Page 240

    Proprietary information confidential material hardware not for customer distribution 240 aeroset ® system troubleshooting 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... T...

  • Page 241

    Proprietary information confidential material not for customer distribution hardware aeroset ® system troubleshooting guide 241 94816-107—november 2004 7. Select cw > (clockwise) or ccw > (counterclockwise) as needed to center the probe over the reagent cartridge. Note: if unable to align the reagen...

  • Page 242

    Proprietary information confidential material hardware not for customer distribution 242 aeroset ® system troubleshooting guide 94816-107—november 2004 r1a probe wash cup alignment 1. Select the maintenance utilities icon in the action area of the main display. The maintenance utilities screen displ...

  • Page 243

    Proprietary information confidential material not for customer distribution hardware aeroset ® 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 o...

  • Page 244

    Proprietary information confidential material hardware not for customer distribution 244 aeroset ® system troubleshooting guide 94816-107—november 2004 7. Select cw > (clockwise) or ccw > (counterclockwise) as needed to center the probe over the wash cup. 8. Select to save the position. 9. Select rg...

  • Page 245: Troubleshooting

    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

    Proprietary information confidential material not for customer distribution flowcharts aeroset ® system troubleshooting guide 247 94816-107—november 2004 abbott assay—basic assay troubleshooting customer perceive assay is performing as expected? Can performance change be traced to a certain event or...

  • Page 248

    Proprietary information confidential material flowcharts not for customer distribution 248 aeroset ® system troubleshooting guide 94816-107—november 2004 abbott assay—basic assay troubleshooting, continued assay characteristics if multiple assays are affected, look for similar characteristics such a...

  • Page 249

    Proprietary information confidential material not for customer distribution flowcharts aeroset ® system troubleshooting 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, an...

  • Page 250

    Proprietary information confidential material flowcharts not for customer distribution 250 aeroset ® system troubleshooting guide 94816-107—november 2004 non-abbott assay—basic assay troubleshooting system error log messages no only affected assay? What is concern? Illegal assay configuration: note ...

  • Page 251: (Illegal Configuration)

    Proprietary information confidential material not for customer distribution flowcharts aeroset ® system troubleshooting guide 251 94816-107—november 2004 confirmation of assay parameter settings (illegal configuration) check if reagent or diluent is onboard. Ok? Reagent or diluent manually configure...

  • Page 252: Configuration), Continued

    Proprietary information confidential material flowcharts not for customer distribution 252 aeroset ® system troubleshooting guide 94816-107—november 2004 confirmation of assay parameter settings (illegal configuration), continued if everything is ok, and assay is still illegally configured (assay te...

  • Page 253: Erratic Results

    Proprietary information confidential material not for customer distribution flowcharts aeroset ® system troubleshooting guide 253 94816-107—november 2004 erratic results multiple assays? Probes dripping? Probes centered? No yes no no edit assay recalibrate edit set points reagent expired? All m aint...

  • Page 254: Qc Out of Range

    Proprietary information confidential material flowcharts not for customer distribution 254 aeroset ® system troubleshooting guide 94816-107—november 2004 qc out of range multiple assays? Verify calibration. Check cal values, cal prep, & expiration. Ok? Verify system. Ok? Yes observed problem: qc out...

  • Page 255: Qc Out of Range, Continued

    Proprietary information confidential material not for customer distribution flowcharts aeroset ® system troubleshooting guide 255 94816-107—november 2004 qc out of range, continued 1. Check for the following: • involved assays on same line? • involved assays using similar wavelengths? • is the reage...

  • Page 256

    Proprietary information confidential material flowcharts not for customer 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 a...

  • Page 257: Calibration Errors

    Proprietary information confidential material not for customer distribution flowcharts aeroset ® system troubleshooting guide 257 94816-107—november 2004 calibration errors calibration error generated? Qc oor? No yes ict™ calibration failed? No yes no check calibrator concentration, carousel locatio...

  • Page 258

    Proprietary information confidential material flowcharts not for customer distribution 258 aeroset ® system troubleshooting guide 94816-107—november 2004 calibration errors, continued no yes no 6. Replace lamp & recalibrate. Ok? Service 5. Check dispense components. Ok? No adjust, replace, or clean ...

  • Page 259: Ict™ Failed Calibration

    Proprietary information confidential material not for customer distribution flowcharts aeroset ® system troubleshooting guide 259 94816-107—november 2004 ict™ failed calibration review error codes & troubleshoot per operations manual. Resolved? Bubbles in ict module tubing or 1 ml syringe? No determ...

  • Page 260

    Proprietary information confidential material flowcharts not for customer distribution 260 aeroset ® system troubleshooting guide 94816-107—november 2004 ict™ failed calibration, continued b ict diluent cartridge empty or expired? No replace ict diluent cartridge yes bubbles in iref solution bottle ...

  • Page 261

    Proprietary information confidential material not for customer distribution flowcharts aeroset ® system troubleshooting guide 261 94816-107—november 2004 bubbles in ict™ module tubing ict reference solution empty, or volume too low for the filter to reach? Ict reference solution tubing all the way d...

  • Page 262: Lis/communication Problems

    Proprietary information confidential material flowcharts not for customer distribution 262 aeroset ® system troubleshooting guide 94816-107—november 2004 lis/communication problems cycle power in this order to establish handshake: host down/aeroset down/host up/aeroset up yes error log message? Bar ...

  • Page 263

    Proprietary information confidential material not for customer distribution flowcharts aeroset ® system troubleshooting guide 263 94816-107—november 2004 lis/communication problems, continued 4. Host icon with green line through it (or not blue)? Host cable connected? Connect cable cycle power verif...

  • Page 264: Water Issue

    Proprietary information confidential material flowcharts not for customer distribution 264 aeroset ® system troubleshooting guide 94816-107—november 2004 water issue stop service 1 plug in 2 turn on 3 use another outlet light on? Check external water carboy; water present? Yes error log messages 99,...