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Test parameters
D_Bil Version number 3 . 1

Date 31.1.2017 Check the reagent insert info

Time 15:55:44 Software version: 6.0
Info
Tag D15610
Barcode 1 Barcode 2
Last time changed 31.1.2017 15:49
User name <root user>
Full name Bilirubin Direct,
REF 981909
Type Photometric
Online name
Acceptance Automatic
Result unit µmol/l
Number of decimals 1
Correction factor 1
Correction bias 0
Sample type Serum,Plasma

Flow
Blank type Yes Primary dilution 1 + 0 Dispensed volume 150

CE-marked application for Indiko™ by Thermo Fisher Scientific Oy, applicable for
use outside the US. Prior to change.
 Page 2 / 3
Test parameters
D_Bil Version number 3 . 1

Date 31.1.2017 Check the reagent insert info

Time 15:55:44 Software version: 6.0
Reagent Reagent Volume (µl) Dispense with Extra volume (µl) Syringe speed Replacing reagent

D_Bil A 100 Extra 20 Normal None

Barcode ID Alarm limit (ml) Onboard stability (days)

352 2.0 30

Sample Volume (µl) Dispense with Extra volume (µl) Extra wash

5 Water 20 No

Incubate Time (sec) Actual time (sec)

300 297

End-point blank Blank resp. min.(A) Blank resp. max.(A)

0 *

Reagent Reagent Volume (µl) Dispense with Extra volume (µl) Syringe speed Replacing reagent

D_Bil B 25 Extra 10 Normal None

Barcode ID Alarm limit (ml) Onboard stability (days)

353 2.0 30

Incubate Time (sec) Actual time (sec)

300 297

End-point Main wavelength (nm) Side wavelength (nm) Residual net abs. (A)
measurement
540 None 0

Dilution Limits
Measuring range (µmol/l) Sec. dilution 1 +
Dilution with Water
Min Max Min Max
Primary dilution 1 + 0
Dilution limit * 170.00 * 6.0

Test limit 1.00 1 190.00 µmol/l

Critical limit * * µmol/l
Init. abs. -0.002 2 A

Cut Off Levels

Limit 1 Limit 2
* * µmol/l

CE-marked application for Indiko™ by Thermo Fisher Scientific Oy, applicable for
use outside the US. Prior to change.
 Page 3 / 3
Test parameters
D_Bil Version number 3 . 1

Date 31.1.2017 Check the reagent insert info

Time 15:55:44 Software version: 6.0

Calibration

Calibration type Linear Abs. error (A) 0.003

Repeat time (days) Rel. error (%) 3

14
Factor limit min. 400.000
Points/calibrator Duplicate
Factor limit max. 700.000
Acceptance Manual
Bias limit min. -0.003
Nbr Calibrator Current lot Concentration Dilution 1 + Bias limit max. 0.003

1 Water Default 0.00 0

2 sCal M734 21.50 0 Concentration axis Linear
Response axis Linear

QC

Procedure 1 QC profile

Interval type Time (hh:mm) In use Yes

Requests Acceptance Automatic

Time (hh:mm) 12:00 Trigger Calibration,Interval,Reagent lot change,Reagent vial change

Procedure Control Current Lot Conc. SD Req. count

1 Abtrol L260 36.3 2.54 1

1 Nortrol L680 13.7 0.96 1

Procedure Nbr of controls SD multiplier

1 1 2

Wash definition
Preceding reagent Following reagent Wash type Wash reagent Tag

All U-CSF Prot Reagent (large) WashFluid x

All Lipase A Reagent (large) WashFluid x
All Lipase B Reagent (large) WashFluid x
D_Bil A LDL A Reagent (medium) WashFluid x
D_Bil A LDL B Reagent (medium) WashFluid x
D_Bil B LDL A Reagent (medium) WashFluid x
D_Bil B LDL B Reagent (medium) WashFluid x

CE-marked application for Indiko™ by Thermo Fisher Scientific Oy, applicable for
use outside the US. Prior to change.