January 2007/2

Immunoglobulin E FS

ADVIA 1200 – CHEMISTRY PARAMETERS

Analytical conditions Sub-analy. conditions

R1 volume 60 Name IgE

R2e volume 0 Digits 1

R2 volume 30 M-wave L. 570

R1 diluent vol 0 S-wave.L

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. MSTD

Sample Vol (S) 1,5 Qualit. Judge Not do

Sample Vol (U) 1,5 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 41

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 22

Sample Type Serum S-DET.P.r 23

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1,5 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction Do

Liquid volume correction Do Prozone Prozone formula

Reaction sample volume 1,5 Prozone limit 1,8

Diluent method No dilution Prozone judge Upper limit

Undiluted sample volume 0 Judge limit 9,999

Diluent volume 0,000 M-DET.P.m 34

Diluent position 0 M-DET.P.n 35

Diluent volume from RPP 0,000 S-DET.P.p 0

Rerun conditions set S-DET.P.r 0

Absorbance limit (u) D1

Absorbance limit (d) D2 Endpoint method

Effect.nbr.o.pnts (n) Re.absorb (u) 0,38

Abnormal val.limit (h) D1 Re.absorb (d) 0,012

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1,5 Serum reac.smp.vol (u) 1,5

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 3 Serum reac.smp.vol (u) 3

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 3 Dilute 3

Serum reac.smp.vol (u) 1,5 Serum reac.smp.vol (u) 1

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 10 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

January 2007/2

Standard settings MULTI-STD

Formula Spline correction Axis conv No convert

Blank passes Points 6

Pos. FV Reac.samp. vol.

Dil. Method Dil.samp. vol.

Diluent volume

Diluent posit.

Diluent volume

STD H STD L

BLK 0 1,5 No dilution 0,000 0,000 0 0,000 9,999 -9,999

1 50 1,5 No dilution 0,000 0,000 0 0,000 9,999 -9,999

2 100 1,5 No dilution 0,000 0,000 0 0,000 9,999 -9,999

3 200 1,5 No dilution 0,000 0,000 0 0,000 9,999 -9,999

4 500 1,5 No dilution 0,000 0,000 0 0,000 9,999 -9,999

5 1000 1,5 No dilution 0,000 0,000 0 0,000 9,999 -9,999

6 No dilution 0,000 0,000 0 0,000 9,999 -9,999

7 No dilution 0,000 0,000 0 0,000 9,999 -9,999

8 No dilution 0,000 0,000 0 0,000 9,999 -9,999

9 No dilution 0,000 0,000 0 0,000 9,999 -9,999

Order information Cat. No. 1 7239 .. .. …

Notes

1. Please refer to the package insert for Immunoglobulin E FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

November 2008/1

Uric Acid FS TBHBA

Cat. No 1 3021.........

Notes 1. Please refer to the package insert for Uric Acid TBHBA FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name UA

R2e volume 0 Digits 1

R2 volume 20 M-wave L. 505

R1 diluent vol 0 S-wave.L 694

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 2 Qualit. Judge Not do

Sample Vol (U) 2 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 40

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 18

Sample Type Serum S-DET.P.r 19

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 2 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u)

Diluent volume from RPP 0,000 Blank (d)

Sample Type Urine Sample (u)

Dilution specification Do Sample (d)

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 2 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 2 Serum reac.smp.vol (u) 2

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 10 Serum reac.smp.vol (u) 10

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

November 2008/1

APLICAÇÕES Advia 1200

ALBUMINA DIASYS

Analytical conditions

R1 volume 100.0 Sub Param. 46 1 Up Down

R2e volume 0.00 Sub-analy-conditions Standards setting

R3 volume 0.00 Name Alb FV *** BLK-L -9.999 STD H -9.999 Multi-STD Setting

Digits 1 BLK-H 9.9999 STD L 9.9999 Error judge rare

R1 Extra vol H-wave.L. 596nm

R2 Extra vol S-wave.L. 694nm

R3 Extra vol Anal.mthd EPA

R1 diluent vol 0.00 Calc.mthd STD

R2e diluent vol 0.00

Quali.judg Not do

R3 diluent vol 0.00 CCalculation method setting

Sample Vol( S ) 1,0 M-DET.P.1 0 S-DETP.p. 0 Reac.typ Inc

Sample vol (U) 1,0 Qualit. Judgment set M-DET.P.m 41 S-DET.P.r 0 Reaction rate method

Real time correct form M-DET.P.n 42 Cycle 2

Reanalysis conditions Check D.P.I 0 Factor 2.0

Rerun conditions set Limit value 0.003 E2 corre Not do

Reagent 1 stir Weak Mark setting Variance 10.0 Blank(µ) 9.9999

Reagent 2e stir Weak Normal Value setting * Prozone Blank(d) -9.9999

Reagent 2 stir Weak Abnormal value setting Prozone form None Sample(µ) 9.9999

Reaction Time 10 min. Prozone limit 9.999 Sample

(d)

-9.9999

Prozone judge Upper limit

Anaysis item

Condition setting (M)

Judge limit 9.999 * Endpoint method

M-DET.P.m 0 S-DET.P.p 0 Re.absorb(µ) 9.9999

M-DET.P.n 0 S-DET.P.r 0 Re.absorb(d) -9.9999

IMA setting

Setting

Allowance

Metodologia: Verde de Bromocresol

Valor de Referência: 3,5 – 5,2 g/dL

Linearidade: 6,0 g/dL

Apresentação: 5 x 25 mL Rendimento 1014 testes

APLICAÇÕES Advia 1200

AMILASE DIASYS

Analytical conditions

R1 volume 80.00 Sub Param. 46 1 Up Down

R2e volume 0.00 Sub-analy-conditions Standards setting

R3 volume 20.00 Name Ami

FV

6300 BLK-L -9.999 STD H -9.999 Multi-STD Setting

Digits 0 BLK-H 9.9999 STD L 9.9999 Error judge rare

R1 Extra vol H-wave.L. 410nm

R2 Extra vol S-wave.L. 694nm

R3 Extra vol Anal.mthd RRA

R1 diluent vol 0.00 Calc.mthd ABB

R2e diluent vol 0.00

Quali.judg Not do

R3 diluent vol 0.00 CCalculation method setting

Sample Vol( S ) 6,0 M-DET.P.1 25 S-DETP.p. 0 Reac.typ Inc

Sample vol (U) 6,0 Qualit. Judgment set M-DET.P.m 34 S-DET.P.r 0 Reaction rate method

Real time correct form M-DET.P.n 42 Cycle 2

Reanalysis conditions Check D.P.I 21 Factor 2.0

Rerun conditions set Limit value 0.003 E2 corre Not do

Reagent 1 stir Weak Mark setting Variance 10.0 Blank(µ) 0,2270

Reagent 2e stir Weak Normal Value setting * Prozone Blank(d) 0,0110

Reagent 2 stir Weak Abnormal value setting Prozone form None Sample(µ) 1,2000

Reaction Time 10 min. Prozone limit 9.999 Sample

(d)

0,0110

Prozone judge Upper limit

Anaysis item

Condition setting (M)

Judge limit 9.999 * Endpoint method

M-DET.P.m 0 S-DET.P.p 0 Re.absorb(µ) 9.9999

M-DET.P.n 0 S-DET.P.r 0 Re.absorb(d) -9.9999

IMA setting

Setting

Allowance

Metodologia: CNP G7

Valor de Referência: < 1000 U/L

Linearidade: 1000 U/L

Apresentação: 5 x 20 mL

1 x 25 mL Rendimento = 740 testes

February 2006/2

APOLIPOPROTEIN A1 FS

Cat. No 1 7102.........

Notes 1. Please refer to the package insert for Apoliporotein A1 FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 100 Name APO A1

R2e volume 0 Digits 2

R2 volume 20 M-wave L. 570

R1 diluent vol 0 S-wave.L

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. MSTD

Sample Vol (S) 1 Qualit. Judge Not do

Sample Vol (U) 1 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 41

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 17

Sample Type Serum S-DET.P.r 18

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 1 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1 Serum reac.smp.vol (u) 1

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 2 Serum reac.smp.vol (u) 2

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

February 2006/2

Standard settings MULTI-STD

Formula Logit Log 3 Axis conv No convert

Blank passes Points 5

Pos. FV Reac.smp.vol.

Dil. Method Dil.smp.vol.

Diluent volume

Diluent posit.

Diluent volume

STD H STD L

BLK 1 0 1 No dilution 0,000 0,000 0 0,000 9,999 -9,999

1 2 0.2 1 A dilution 20 20 1 0,000 9,999 -9,999

2 2 0.4 1 No dilution 0,000 0,000 0 0,000 9,999 -9,999

3 3 1.22 1 No dilution 0,000 0,000 0 0,000 9,999 -9,999

4 4 2.62 1 No dilution 0,000 0,000 0 0,000 9,999 -9,999

5 No dilution 0,000 0,000 0 0,000 9,999 -9,999

6 No dilution 0,000 0,000 0 0,000 9,999 -9,999

7 No dilution 0,000 0,000 0 0,000 9,999 -9,999

8 No dilution 0,000 0,000 0 0,000 9,999 -9,999

9 No dilution 0,000 0,000 0 0,000 9,999 -9,999

February 2006/2

APOLIPOPROTEIN B FS

Cat. No 1 7112.........

Notes 1. Please refer to the package insert for Apoliporotein B FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 100 Name APO B

R2e volume 0 Digits 2

R2 volume 20 M-wave L. 340

R1 diluent vol 0 S-wave.L

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. MSTD

Sample Vol (S) 1 Qualit. Judge Not do

Sample Vol (U) 1 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 41

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 17

Sample Type Serum S-DET.P.r 18

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 1 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1 Serum reac.smp.vol (u) 1

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 2 Serum reac.smp.vol (u) 2

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

February 2006/2

Standard settings MULTI-STD

Formula Logit Log 3 Axis conv No convert

Blank passes Points 5

Pos. FV Reac.smp.vol.

Dil. Method Dil.smp.vol.

Diluent volume

Diluent posit.

Diluent volume

STD H STD L

BLK 1 0 1 No dilution 0,000 0,000 0 0,000 9,999 -9,999

1 2 0.2 1 A dilution 20 20 1 0,000 9,999 -9,999

2 2 0.4 1 No dilution 0,000 0,000 0 0,000 9,999 -9,999

3 3 1.27 1 No dilution 0,000 0,000 0 0,000 9,999 -9,999

4 4 2.54 1 No dilution 0,000 0,000 0 0,000 9,999 -9,999

5 No dilution 0,000 0,000 0 0,000 9,999 -9,999

6 No dilution 0,000 0,000 0 0,000 9,999 -9,999

7 No dilution 0,000 0,000 0 0,000 9,999 -9,999

8 No dilution 0,000 0,000 0 0,000 9,999 -9,999

9 No dilution 0,000 0,000 0 0,000 9,999 -9,999

February 2008/1

Bicarbonate FS

Cat. No 1 0950.........

Notes 1. Please refer to the package insert Bicarbonate FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 100 Name CO2

R2e volume 0 Digits 1

R2 volume 0 M-wave L. 410

R1 diluent vol 0 S-wave.L 505

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 1.1 Qualit. Judge Not do

Sample Vol (U) 1.1 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 36

Reagent 2 stir Weak M-DET.P.n 38

Reaction time 10 S-DET.P.p 3

Sample Type Serum S-DET.P.r 4

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1.1 Reac.typ Decrease

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u)

Diluent volume from RPP 0,000 Blank (d)

Sample Type Urine Sample (u)

Dilution specification Do Sample (d)

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 1.1 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1.1 Serum reac.smp.vol (u) 1.1

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 2.2 Serum reac.smp.vol (u) 2.2

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

November 2008/1

Bilirubin Auto Direct FS

Cat. No 1 0821.........

Notes 1. Please refer to the package insert for Bilirubin Auto Direct FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name DBIL

R2e volume 0 Digits 1

R2 volume 20 M-wave L. 545

R1 diluent vol 0 S-wave.L 694

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 6 Qualit. Judge Not do

Sample Vol (U) 6 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 40

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 18

Sample Type Serum S-DET.P.r 19

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 6 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u)

Diluent volume from RPP 0,000 Blank (d)

Sample Type Urine Sample (u)

Dilution specification Do Sample (d)

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 6 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 6 Serum reac.smp.vol (u) 6

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 10 Serum reac.smp.vol (u) 10

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

November 2008/1

May 2009/2

Bilirubin Auto Total FS

Cat. No 1 0811.........

Notes 1. Please refer to the package insert for Bilirubin Auto Total FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name TBIL

R2e volume 0 Digits 2

R2 volume 20 M-wave L. 545

R1 diluent vol 0 S-wave.L 658

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 2 Qualit. Judge Not do

Sample Vol (U) 2 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 39

Reagent 2 stir Weak M-DET.P.n 40

Reaction time 10 S-DET.P.p 16

Sample Type Serum S-DET.P.r 18

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 2 Reac.typ Inc.

Diluent method No dilution Cykle 3

Undiluted sample volume 0 Factor 3

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u) 9.999

Diluent volume from RPP 0,000 Blank (d) -9.999

Sample Type Urine Sample (u) 9.999

Dilution specification Do Sample (d) -9.999

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 2 Re.absorb (u) 1.200

Diluent method No dilution Re.absorb (d) -9.999

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 2 Serum reac.smp.vol (u) 2

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 10 Serum reac.smp.vol (u) 10

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

May 2009/2

APLICAÇÕES Advia 1200

CÁLCIO DIASYS

Analytical conditions

R1 volume 100.0 Sub Param. 46 1 Up Down

R2e volume 0.00 Sub-analy-conditions Standards setting

R3 volume 0.00 Name Ca FV *** BLK-L -9.999 STD H -9.999 Multi-STD Setting

Digits 1 BLK-H 9.9999 STD L 9.9999 Error judge rare

R1 Extra vol H-wave.L. 658nm

R2 Extra vol S-wave.L. *******

R3 Extra vol Anal.mthd EPA

R1 diluent vol 0.00 Calc.mthd STD

R2e diluent vol 0.00

Quali.judg Not do

R3 diluent vol 0.00 CCalculation method setting

Sample Vol( S ) 1,0 M-DET.P.1 0 S-DETP.p. 0 Reac.typ Inc

Sample vol (U) 1,0 Qualit. Judgment set M-DET.P.m 18 S-DET.P.r 0 Reaction rate method

Real time correct form M-DET.P.n 19 Cycle 2

Reanalysis conditions Check D.P.I 0 Factor 2.0

Rerun conditions set Limit value 0.003 E2 corre Not do

Reagent 1 stir Weak Mark setting Variance 10.0 Blank(µ) 9.9999

Reagent 2e stir Weak Normal Value setting * Prozone Blank(d) -9.9999

Reagent 2 stir Weak Abnormal value setting Prozone form None Sample(µ) 9.9999

Reaction Time 10 min. Prozone limit 9.999 Sample

(d)

-9.9999

Prozone judge Upper limit

Anaysis item

Condition setting (M)

Judge limit 9.999 * Endpoint method

M-DET.P.m 0 S-DET.P.p 0 Re.absorb(µ) 9.9999

M-DET.P.n 0 S-DET.P.r 0 Re.absorb(d) -9.9999

IMA setting

Setting

Allowance

Método: Arsenazo

Valor de Referência: 8,6 – 10,3 mg/dL

Linearidade: 25 mg/dL

Apresentação: 4 x 25 mL Rendimento 1014 testes

APLICAÇÕES Advia 1200

CKMB DIASYS

Analytical conditions

R1 volume 80.00 Sub Param. 46 1 Up Down

R2e volume 0.00 Sub-analy-conditions Standards setting

R3 volume 20.00 Name CKMB FV *** BLK-L -9.999 STD H -9.999 Multi-STD Setting

Digits 0 BLK-H 9.9999 STD L 9.9999 Error judge rare

R1 Extra vol H-wave.L. 340nm

R2 Extra vol S-wave.L. 410nm

R3 Extra vol Anal.mthd RRA

R1 diluent vol 0.00 Calc.mthd ABS

R2e diluent vol 0.00

Quali.judg Not do

R3 diluent vol 0.00 CCalculation method setting

Sample Vol( S ) 4,0 M-DET.P.1 0 S-DETP.p. 0 Reac.typ Inc

Sample vol (U) 4,0 Qualit. Judgment set M-DET.P.m 28 S-DET.P.r 0 Reaction rate method

Real time correct form M-DET.P.n 40 Cycle 2

Reanalysis conditions Check D.P.I 0 Factor 2.0

Rerun conditions set Limit value 0.003 E2 corre Not do

Reagent 1 stir Weak Mark setting Variance 10.0 Blank(µ) 9.9999

Reagent 2e stir Weak Normal Value setting * Prozone Blank(d) -9.9999

Reagent 2 stir Weak Abnormal value setting Prozone form None Sample(µ) 9.9999

Reaction Time 10 min. Prozone limit 9.999 Sample

(d)

9.9999

Prozone judge Upper limit

Anaysis item

Condition setting (M)

Judge limit 9.999 * Endpoint method

M-DET.P.m 0 S-DET.P.p 0 Re.absorb(µ) 9.9999

M-DET.P.n 0 S-DET.P.r 0 Re.absorb(d) -9.9999

IMA setting

Setting

Allowance

Método: UV Otimizado - DGKC

Valor de Referência< 24 U/L

Linearidade: 200 U/L

Apresentação: 4 x 20 mL

1 x 20 mL Rendimento 594 testes

APLICAÇÕES Advia 1200

CK DIASYS

Analytical conditions

R1 volume 80.00 Sub Param. 46 1 Up Down

R2e volume 0.00 Sub-analy-conditions Standards setting

R3 volume 20.00 Name CKNAC FV 4600 BLK-L -9.999 STD H -9.999 Multi-STD Setting

Digits 0 BLK-H 9.9999 STD L 9.9999 Error judge rare

R1 Extra vol H-wave.L. 340nm

R2 Extra vol S-wave.L. 410nm

R3 Extra vol Anal.mthd RRA

R1 diluent vol 0.00 Calc.mthd ABS

R2e diluent vol 0.00

Quali.judg Not do

R3 diluent vol 0.00 CCalculation method setting

Sample Vol( S ) 4,0 M-DET.P.1 0 S-DETP.p. 0 Reac.typ Inc

Sample vol (U) 4,0 Qualit. Judgment set M-DET.P.m 25 S-DET.P.r 0 Reaction rate method

Real time correct form M-DET.P.n 42 Cycle 2

Reanalysis conditions Check D.P.I 0 Factor 2.0

Rerun conditions set Limit value 0.003 E2 corre Not do

Reagent 1 stir Weak Mark setting Variance 10.0 Blank(µ) 0,5400

Reagent 2e stir Weak Normal Value setting * Prozone Blank(d) 0,1300

Reagent 2 stir Weak Abnormal value setting Prozone form None Sample(µ) 1,2100

Reaction Time 5 min. Prozone limit 9.999 Sample

(d)

0,1300

Prozone judge Upper limit

Anaysis item

Condition setting (M)

Judge limit 9.999 * Endpoint method

M-DET.P.m 0 S-DET.P.p 0 Re.absorb(µ) 9.9999

M-DET.P.n 0 S-DET.P.r 0 Re.absorb(d) -9.9999

IMA setting

Setting

Allowance

Método: UV Otimizado – DGKC e IFCC

Valor de Referência: M: < 145 U

H: < 171 U/L

Linearidade: 1000 U/L

Apresentação: 5 x 20 mL

1 x 25 mL Rendimento 740 testes

APLICAÇÕES Advia 1200

CLORO DIASYS

Analytical conditions

R1 volume 100.0 Sub Param. 46 1 Up Down

R2e volume 0.00 Sub-analy-conditions Standards setting

R3 volume 0.00 Name Clor FV *** BLK-L -9.999 STD H -9.999 Multi-STD Setting

Digits 0 BLK-H 9.9999 STD L 9.9999 Error judge rare

R1 Extra vol H-wave.L. 451nm

R2 Extra vol S-wave.L. ******

R3 Extra vol Anal.mthd EPA

R1 diluent vol 0.00 Calc.mthd STD

R2e diluent vol 0.00

Quali.judg Not do

R3 diluent vol 0.00 CCalculation method setting

Sample Vol( S ) 1,0 M-DET.P.1 0 S-DETP.p. 0 Reac.typ Inc

Sample vol (U) 1,0 Qualit. Judgment set M-DET.P.m 18 S-DET.P.r 0 Reaction rate method

Real time correct form M-DET.P.n 19 Cycle 3

Reanalysis conditions Check D.P.I 0 Factor 3.0

Rerun conditions set Limit value 0.003 E2 corre Not do

Reagent 1 stir Weak Mark setting Variance 10.0 Blank(µ) 9.9999

Reagent 2e stir Weak Normal Value setting * Prozone Blank(d) -9.9999

Reagent 2 stir Weak Abnormal value setting Prozone form None Sample(µ) 9.9999

Reaction Time 5 min. Prozone limit 9.999 Sample

(d)

-9.9999

Prozone judge Upper limit

Anaysis item

Condition setting (M)

Judge limit 9.999 * Endpoint method

M-DET.P.m 0 S-DET.P.p 0 Re.absorb(µ) 9.9999

M-DET.P.n 0 S-DET.P.r 0 Re.absorb(d) -9.9999

IMA setting

Setting

Allowance

Método: Colorimétrico - Tiocianato

Valor de Referência: 95 – 105 mEq/L

Linearidade: 130 mEq/L

Apresentação : 5 x 25 mL Rendimento 1014 testes

February 2006/2

CHOLESTEROL FS

Cat. No 1 1300.........

Notes 1. Please refer to the package insert for Cholesterol FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 100 Name CHOL

R2e volume 0 Digits 2

R2 volume 0 M-wave L. 505

R1 diluent vol 0 S-wave.L 694

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 1.1 Qualit. Judge Not do

Sample Vol (U) 1.1 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 40

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 0

Sample Type Serum S-DET.P.r 0

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1.1 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 1.1 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1.1 Serum reac.smp.vol (u) 1.1

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 2.2 Serum reac.smp.vol (u) 2.2

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

February 2006/2

February 2008/1

Cholinesterase FS

Cat. No 1 1401.........

Notes 1. Please refer to the package insert for Cholinesterase FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name CHE

R2e volume 0 Digits 0

R2 volume 20 M-wave L. 410

R1 diluent vol 0 S-wave.L

R2e diluent vol 0 Analy.Methd. RRA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 1.5 Qualit. Judge Not do

Sample Vol (U) 1.5 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 21

Reagent 2e stir Weak M-DET.P.m 24

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 0

Sample Type Serum S-DET.P.r 0

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1.5 Reac.typ Decrease

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u)

Diluent volume from RPP 0,000 Blank (d)

Sample Type Urine Sample (u)

Dilution specification Do Sample (d)

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 1.5 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1 Serum reac.smp.vol (u) 1.5

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 3 Serum reac.smp.vol (u) 3

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

February 2006/2

CREATININE FS

Cat. No 1 1711.........

Notes 1. Please refer to the package insert for Creatinine FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 100 Name CREAT

R2e volume 0 Digits 2

R2 volume 25 M-wave L. 505

R1 diluent vol 0 S-wave.L 571

R2e diluent vol 0 Analy.Methd. RRA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 5 Qualit. Judge Not do

Sample Vol (U) 5 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 21

Reagent 2e stir Weak M-DET.P.m 26

Reagent 2 stir Weak M-DET.P.n 32

Reaction time 10 S-DET.P.p 14

Sample Type Serum S-DET.P.r 18

Dilution specification Do Check D.P.I. 21

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 5 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Do

Diluent position 0 Blank (u) 0.12

Diluent volume from RPP 0,000 Blank (d) 0.0240

Sample Type Urine Sample (u) 0.5

Dilution specification Do Sample (d) 0.024

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 5 Re.absorb (u)

Diluent method A dilution Re.absorb (d)

Undiluted sample volume 5 Rerun conditions set

Diluent volume 245 Absorbance limit (u) D1

Diluent position 1 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 5 Serum reac.smp.vol (u) 5

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 2

Diluent volume 40 Diluent volume 250

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 10 Serum reac.smp.vol (u) 5

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

Application Advia 1200/C July 2011/3

Creatinine PAP FS ADVIA 1200/2400

Order information Cat. No. 1 1759 99 10 950 Chemistry code – 79 175

Notes 1. Please refer to the package insert for Creatinine PAP FS for detailed information about the test on the following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity / Interferences / Sensitivity / Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature 2. The stability of the reagent on board the analyser is 6 weeks provided that contamination and evaporation are avoided. 3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany. This application was set up and evaluated by DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons

June 2008/1

FERRITIN FS

Cat. No 1 7059.........

Notes 1. Please refer to the package insert for Ferritin FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name FERR

R2e volume 0 Digits 2

R2 volume 40 M-wave L. 571

R1 diluent vol 0 S-wave.L 805

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. MSTD

Sample Vol (S) 4 Qualit. Judge Not do

Sample Vol (U) 4 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 33

Reagent 2 stir Weak M-DET.P.n 34

Reaction time 10 S-DET.P.p 22

Sample Type Serum S-DET.P.r 22

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 4 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 4 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1 Serum reac.smp.vol (u) 4

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 4 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 8 Serum reac.smp.vol (u) 8

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

June 2008/1

Standard settings MULTI-STD

Formula Spline Axis conv No convert

Blank passes Points 5

Pos. FV Reac.smp.vol.

Dil. Method Dil.smp.vol.

Diluent volume

Diluent posit.

Diluent volume

STD H STD L

BLK 1 0 4 No dilution 0,000 0,000 0 0,000 9,999 -9,999

1 2 100 4 No dilution 0,000 0,000 0 0,000 9,999 -9,999

2 3 200 4 No dilution 0,000 0,000 0 0,000 9,999 -9,999

3 4 500 4 No dilution 0,000 0,000 0 0,000 9,999 -9,999

4 5 1000 4 No dilution 0,000 0,000 0 0,000 9,999 -9,999

5 No dilution 0,000 0,000 0 0,000 9,999 -9,999

6 No dilution 0,000 0,000 0 0,000 9,999 -9,999

7 No dilution 0,000 0,000 0 0,000 9,999 -9,999

8 No dilution 0,000 0,000 0 0,000 9,999 -9,999

9 No dilution 0,000 0,000 0 0,000 9,999 -9,999

May 2009/3

IRON FS Ferene

Cat. No 1 1911.........

Notes 1. Please refer to the package insert for Iron FS Ferene for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name FE

R2e volume 0 Digits 2

R2 volume 20 M-wave L. 596

R1 diluent vol 0 S-wave.L 694

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 5 Qualit. Judge Not do

Sample Vol (U) 5 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 40

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 18

Sample Type Serum S-DET.P.r 19

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 5 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u)

Diluent volume from RPP 0,000 Blank (d)

Sample Type Urine Sample (u)

Dilution specification Do Sample (d)

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 5 Re.absorb (u) 9.999

Diluent method No dilution Re.absorb (d) -9.999

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 5 Serum reac.smp.vol (u) 5

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 10 Serum reac.smp.vol (u) 10

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

May 2009/3

APLICAÇÕES Advia 1200

FOSFATASE ALCALINA DIASYS

Analytical conditions

R1 volume 80.00 Sub Param. 46 1 Up Down

R2e volume 0.00 Sub-analy-conditions Standards setting

R3 volume 20.00 Name ALPD

FV

4550 BLK-L -9.999 STD H -9.999 Multi-STD Setting

Digits 0 BLK-H 9.9999 STD L 9.9999 Error judge rare

R1 Extra vol H-wave.L. 410nm

R2 Extra vol S-wave.L. 478nm

R3 Extra vol Anal.mthd RRA

R1 diluent vol 0.00 Calc.mthd ABS

R2e diluent vol 0.00

Quali.judg Not do

R3 diluent vol 0.00 CCalculation method setting

Sample Vol( S ) 1,6 M-DET.P.1 21 S-DETP.p. 0 Reac.typ Inc

Sample vol (U) 1,6 Qualit. Judgment set M-DET.P.m 25 S-DET.P.r 0 Reaction rate method

Real time correct form M-DET.P.n 42 Cycle 2

Reanalysis conditions Check D.P.I 21 Factor 2.0

Rerun conditions set Limit value 0.003 E2 corre Not do

Reagent 1 stir Weak Mark setting Variance 10.0 Blank(µ) 0,6000

Reagent 2e stir Weak Normal Value setting * Prozone Blank(d) 0,0200

Reagent 2 stir Weak Abnormal value setting Prozone form None Sample(µ) 1,1770

Reaction Time 10 min. Prozone limit 9.999 Sample

(d)

0,0200

Prozone judge Upper limit

Anaysis item

Condition setting (M)

Judge limit 9.999 * Endpoint method

M-DET.P.m 0 S-DET.P.p 0 Re.absorb(µ) 9.9999

M-DET.P.n 0 S-DET.P.r 0 Re.absorb(d) -9.9999

IMA setting

Setting

Allowance

Método: Enzimático colorinmétrico - IFCC

Linearidade: 1200 U/L

Apresentação: 5 x 20 mL

1 x 25 mL Rendimento 740 Testes

Valor de Referência:

Adultos

Homens 20 a 50 anos 53 – 128 U/L

Homens > 60 anos 56 – 119 U/L

Mulheres 20 a 50 anos 42 – 98 U/L

Mulheres > 60 anos 53 – 141 U/L

Crianças

Unidade Mulheres Homens

1 – 30 dias U/L 48 – 406 75 – 319

1 mes – 1 ano U/L 124 – 341 82 – 383

1 – 3 anos U/L 108 – 317 104 – 345

4 – 6 anos U/L 96 – 297 93 – 309

7 – 9 anos U/L 69 – 325 86 – 315

10 – 12 anos U/L 51 – 332 42 – 362

13 – 15 anos U/L 50 – 162 74 – 390

16 – 18 anos U/L 47 - 119 52 – 171

May 2009/3

GAMMA GT FS (Szasz mod.)

Cat. No 1 2801.........

Notes 1. Please refer to the package insert for Gamma-GT FS (Szasz mod.) for detailed information about the test on the

following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name GGT

R2e volume 0 Digits 2

R2 volume 20 M-wave L. 410

R1 diluent vol 0 S-wave.L 694

R2e diluent vol 0 Analy.Methd. RRA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 3 Qualit. Judge Not do

Sample Vol (U) 3 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 21

Reagent 2e stir Weak M-DET.P.m 24

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 0

Sample Type Serum S-DET.P.r 0

Dilution specification Do Check D.P.I. 21

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 3 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Do

Diluent position 0 Blank (u) 1.47

Diluent volume from RPP 0,000 Blank (d) 0.39

Sample Type Urine Sample (u) 1.74

Dilution specification Do Sample (d) 0.39

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 3 Re.absorb (u) 10.000

Diluent method No dilution Re.absorb (d) -9.999

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1 Serum reac.smp.vol (u) 3

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 6 Serum reac.smp.vol (u) 6

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

May 2009/3

November 2008/1

Glucose GOD FS

Cat. No 1 2500.........

Notes 1. Please refer to the package insert for Glucose GOD FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 100 Name GLUC

R2e volume 0 Digits 2

R2 volume 0 M-wave L. 505

R1 diluent vol 0 S-wave.L 694

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 1.1 Qualit. Judge Not do

Sample Vol (U) 1.1 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 40

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 0

Sample Type Serum S-DET.P.r 0

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1.1 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 1.1 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1.1 Serum reac.smp.vol (u) 1.1

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 2.2 Serum reac.smp.vol (u) 2.2

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

November 2008/1

March 2008/3

oneHbA1c FS

Cat. No 1 3329.........

Notes 1. Please refer to the package insert for oneHbA1c FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name HbA1c

R2e volume 0 Digits 2

R2 volume 40 M-wave L. 658

R1 diluent vol 0 S-wave.L None

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. MSTD

Sample Vol (S) 2.0 Qualit. Judge Not do

Sample Vol (U) 2.0 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 41

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 0

Sample Type Haem S-DET.P.r 0

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 2.0 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 1 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction 0 Prozone 0

Liquid volume correction 0 Endpoint method

Reaction sample volume 2.0 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Haem Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 2.0 Serum reac.smp.vol (u) 2.0

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 4.0 Serum reac.smp.vol (u) 4.0

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

March 2008/3

Standard settings MULTI-STD

Formula Spline Axis conv No convert

Blank passes Points 5

Pos. FV Reac.smp.vol.

Dil. Method Dil.smp.vol.

Diluent volume

Diluent posit.

Diluent volume

STD H STD L

BLK 0 2 No dilution 0,000 0,000 1 0,000 9,999 -9,999

1 2.23 2 No dilution 0,000 0,000 1 0,000 9,999 -9,999

2 6.48 2 No dilution 0,000 0,000 1 0,000 9,999 -9,999

3 8.71 2 No dilution 0,000 0,000 1 0,000 9,999 -9,999

4 12.5 2 No dilution 0,000 0,000 1 0,000 9,999 -9,999

5 No dilution 0,000 0,000 0 0,000 9,999 -9,999

6 No dilution 0,000 0,000 0 0,000 9,999 -9,999

7 No dilution 0,000 0,000 0 0,000 9,999 -9,999

8 No dilution 0,000 0,000 0 0,000 9,999 -9,999

9 No dilution 0,000 0,000 0 0,000 9,999 -9,999

February 2006/2

HDL-C IMMUNO FS

Cat. No 1 3521.........

Notes 1. Please refer to the package insert for HDL-C Immuno FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

. **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name HDL

R2e volume 0 Digits 2

R2 volume 20 M-wave L. 596

R1 diluent vol 0 S-wave.L 694

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 1 Qualit. Judge Not do

Sample Vol (U) 1 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 40

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 17

Sample Type Serum S-DET.P.r 18

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 1 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1 Serum reac.smp.vol (u) 1

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 2 Serum reac.smp.vol (u) 2

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

February 2006/2

February 2006/2

LACTATE FS

Cat. No 1 4001.........

Notes 1. Please refer to the package insert for Lactate FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name LACT

R2e volume 0 Digits 2

R2 volume 20 M-wave L. 340

R1 diluent vol 0 S-wave.L

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 1.3 Qualit. Judge Not do

Sample Vol (U) 1.3 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 41

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 17

Sample Type Serum S-DET.P.r 18

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1.3 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u)

Diluent volume from RPP 0,000 Blank (d)

Sample Type Urine Sample (u)

Dilution specification Do Sample (d)

Dilution correction Not Do

Liquid volume correction Not Do Endpoint method

Reaction sample volume 1.3 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1.3 Serum reac.smp.vol (u) 1.3

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 2.6 Serum reac.smp.vol (u) 2.6

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

February 2006/2

May 2009/3

LDH DGKC FS

Cat. No 1 4201......... Notes 1. Please refer to the package insert for LDH DGKC FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name LDH

R2e volume 0 Digits 2

R2 volume 20 M-wave L. 340

R1 diluent vol 0 S-wave.L 410

R2e diluent vol 0 Analy.Methd. RRA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 3 Qualit. Judge Not do

Sample Vol (U) 3 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 21

Reagent 2e stir Weak M-DET.P.m 26

Reagent 2 stir Weak M-DET.P.n 39

Reaction time 10 S-DET.P.p 0

Sample Type Serum S-DET.P.r 0

Dilution specification Do Check D.P.I. 21

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 3 Reac.typ Dec.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Do

Diluent position 0 Blank (u) 0.6200

Diluent volume from RPP 0,000 Blank (d) 0.110

Sample Type Urine Sample (u) 1.1100

Dilution specification Do Sample (d) 0.110

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 3 Re.absorb (u) 10.000

Diluent method No dilution Re.absorb (d) -9.999

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 3 Serum reac.smp.vol (u) 3

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 6 Serum reac.smp.vol (u) 6

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

February 2006/2

LDL-C SELECT FS

Cat. No 1 4121.........

Notes 1. Please refer to the package insert for LDL-C Select FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

. **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name LDL

R2e volume 0 Digits 2

R2 volume 20 M-wave L. 596

R1 diluent vol 0 S-wave.L 694

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 1 Qualit. Judge Not do

Sample Vol (U) 1 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 40

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 17

Sample Type Serum S-DET.P.r 18

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 1 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1 Serum reac.smp.vol (u) 1

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 2 Serum reac.smp.vol (u) 2

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

February 2006/2

APLICAÇÕES 1200

Lipase - DiaSys

Analytical conditions

R1 volume 100.0 Sub Param. 46 - 1 Up Down Standards setting

R2 volume 0.00 Sub-analy-conditions BLK H 9.99999 Multi-STD Abnml (serum)H 1500

R3 volume 25.0 Nam

e

Lipase Digits 1 BLK-L -9.9999 Abnml (serum)L 0.0

R4 volume 0.00 H-wave.L. 571nm STD H 9.99999

R1 diluent vol 0.00 S-wave.L. 694nm STD L -9.9999

R2 diluent vol 0.00 Analy.mth

d

RRA FV 84,0 Normal value set

* 1

R3 diluent vol 0.00 Calc.

mthd

STD

R4 diluent vol 0.00

Qualit.jud

g

Not do Quality.set

Serum

reac.s.vol.

2,0 Real-time correct.

Form

CCalculation method setting

Serum dil.

method.

Reanalysis conditions M-DET.P.1 22 S-DETP.p. 0

Serum dil.s.vol. Serum reac.smp.vol.

(µ)

2,0 M-DET.P.m 24 S-DET.P.r 0 Reaction rate method

erum dil. volume Serum dilute.method

(µ)

Spe M-DET.P.n 41 Cycle 3

Serum dil. posit. 0 Serum dil.emp.vol. (µ) 15,0 Check D.P.I 21 Factor 1,2

Urine set Serum diluente vol (µ) 120,0 Limit value 0.003 Reac.typ Inc

Reaction time 10 min Serum diluent posi (µ) 0 Variance 10.0 E2 corre Not do

Reagent 1 stir Weak Serum reac.smp.vol (d) ----- * Prozone Blank(µ) 9.999

Reagent 2 stir Weak Serum dilut.method (d) ------- Prozone form None Blank(d) -9.9999

Reagent 3 stir Weak Serum dil.emp.vol.(d) ------ Prozone limit 9.999 Sample (µ) 9.999

Reagent 4 stir Weak Serum diluent vol (d) ------ Prozone judge Upper limit Sample (d) -9.9999

Serum diluent posi (d) 0 Judge limit 9.999 * Endpoint method

M-DET.P.m 0 S-DET.P.p 0 Re.absorb(µ) 9.9999

M-DET.P.n 0 S-DET.P.r 0 Re.absorb(d) -9.9999

Urine set Rerun.cond. IMA setting

* 1 Normal value set : Soro : < 190 U/L

February 2006/2

MAGNESIUM XL FS

Cat. No 1 4610.........

Notes 1. Please refer to the package insert for Magnesium XL FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 100 Name MG

R2e volume 0 Digits 2

R2 volume 0 M-wave L. 545

R1 diluent vol 0 S-wave.L 694

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 1 Qualit. Judge Not do

Sample Vol (U) 1 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 40

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 0

Sample Type Serum S-DET.P.r 0

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 1 Re.absorb (u)

Diluent method A dilution Re.absorb (d)

Undiluted sample volume 10 Rerun conditions set

Diluent volume 40 Absorbance limit (u) D1

Diluent position 1 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1 Serum reac.smp.vol (u) 1

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 10

Diluent volume 40 Diluent volume 90

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 2 Serum reac.smp.vol (u) 2

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

February 2006/2

February 2006/2

CRP U-hs High sensitive (hs) application

Cat. No 1 7045.........

Notes 1. Please refer to the package insert for CRP U-hs for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 50 Name CRP-Hs

R2e volume 0 Digits 2

R2 volume 50 M-wave L. 505

R1 diluent vol 0 S-wave.L 694

R2e diluent vol 0 Analy.Methd. 2PA

R2 diluent vol 0 Calc.Methd. MSTD

Sample Vol (S) 5 Qualit. Judge Not do

Sample Vol (U) 5 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 27

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 0

Sample Type Serum S-DET.P.r 0

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1 Reac.typ Inc.

Diluent method A dilution Cykle 2

Undiluted sample volume 30 Factor 2

Diluent volume 90 E2 corr Not Do

Diluent position 1 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction Do Prozone Prozone formula

Liquid volume correction Do Prozone Limit

Reaction sample volume 5 Prozone Judge Upper Limit

Diluent method A dilution Judge Limit 9.999

Undiluted sample volume 30 M-DET.P.m

Diluent volume 90 M-DET.P.n

Diluent position 1 S-DET.P.p 0

Diluent volume from RPP 0,000 S-DET.P.r 0

Rerun Conditions Set Endpoint Method

Absorbance limit (u) D1 Re.absorb (u) 0.697

Absorbance limit (d) D2 Re.absorb (d) 0.074

Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 5 Serum reac.smp.vol (u) 5

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 5 Serum reac.smp.vol (u) 5

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

February 2006/2

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 3 Dilute 3

Serum reac.smp.vol (u) 10 Serum reac.smp.vol (u) 10

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 10 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

Standard settings MULTI-STD

Formula Logit Log 3 Axis conv No convert

Blank passes Points 6

Pos. FV Reac.smp.vol.

Dil. Method Dil.smp.vol.

Diluent volume

Diluent posit.

Diluent volume

STD H STD L

BLK 1 0 10 No dilution 0,000 0,000 0 0,000 9,999 -9,999

1 * 0.5 10 A dilution 30 90 1 0,000 9,999 -9,999

2 * 2.45 10 A dilution 30 90 1 0,000 9,999 -9,999

3 * 8.45 10 A dilution 30 90 1 0,000 9,999 -9,999

4 * 12.4 10 A dilution 30 90 1 0,000 9,999 -9,999

5 * 20.4 10 A dilution 30 90 1 0,000 9,999 -9,999

6 No dilution 0,000 0,000 0 0,000 9,999 -9,999

7 No dilution 0,000 0,000 0 0,000 9,999 -9,999

8 No dilution 0,000 0,000 0 0,000 9,999 -9,999

9 No dilution 0,000 0,000 0 0,000 9,999 -9,999

February 2006/2

CRP U-hs Universal (U) application

Cat. No 1 7045.........

Notes 1. Please refer to the package insert for CRP U-hs for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 50 Name CRP-U

R2e volume 0 Digits 2

R2 volume 50 M-wave L. 505

R1 diluent vol 0 S-wave.L 805

R2e diluent vol 0 Analy.Methd. 2PA

R2 diluent vol 0 Calc.Methd. MSTD

Sample Vol (S) 2 Qualit. Judge Not do

Sample Vol (U) 2 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 27

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 0

Sample Type Serum S-DET.P.r 0

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 1 Reac.typ Inc.

Diluent method A dilution Cykle 2

Undiluted sample volume 10 Factor 2

Diluent volume 140 E2 corr Not Do

Diluent position 1 Blank (u) 9,999

Diluent volume from RPP 0,000 Blank (d) -9,999

Sample Type Urine Sample (u) 9,999

Dilution specification Do Sample (d) -9,999

Dilution correction Do Prozone Prozone formula

Liquid volume correction Do Prozone Limit

Reaction sample volume 2 Prozone Judge Upper Limit

Diluent method A dilution Judge Limit 9.999

Undiluted sample volume 10 M-DET.P.m

Diluent volume 140 M-DET.P.n

Diluent position 1 S-DET.P.p 0

Diluent volume from RPP 0,000 S-DET.P.r 0

Rerun Conditions Set Endpoint Method

Absorbance limit (u) D1 Re.absorb (u)

Absorbance limit (d) D2 Re.absorb (d)

Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 2 Serum reac.smp.vol (u) 2

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 2 Serum reac.smp.vol (u) 2

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

February 2006/2

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 3 Dilute 3

Serum reac.smp.vol (u) 2 Serum reac.smp.vol (u) 2

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 10 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

Standard settings MULTI-STD

Formula Logit Log 3 Axis conv No convert

Blank passes Points 6

Pos. FV Reac.smp.vol.

Dil. Method Dil.smp.vol.

Diluent volume

Diluent posit.

Diluent volume

STD H STD L

BLK 1 0 10 No dilution 0,000 0,000 0 0,000 9,999 -9,999

1 * 6 10 A dilution 10 140 1 0,000 9,999 -9,999

2 * 65 10 A dilution 10 140 1 0,000 9,999 -9,999

3 * 100 10 A dilution 10 140 1 0,000 9,999 -9,999

4 * 175 10 A dilution 10 140 1 0,000 9,999 -9,999

5 * 350 10 A dilution 10 140 1 0,000 9,999 -9,999

6 No dilution 0,000 0,000 0 0,000 9,999 -9,999

7 No dilution 0,000 0,000 0 0,000 9,999 -9,999

8 No dilution 0,000 0,000 0 0,000 9,999 -9,999

9 No dilution 0,000 0,000 0 0,000 9,999 -9,999

May 2009/2

Total Protein FS

Cat. No 1 2311.........

Notes 1. Please refer to the package insert for Total Protein FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 100 Name TPRO

R2e volume 0 Digits 1

R2 volume 25 M-wave L. 545

R1 diluent vol 0 S-wave.L 0

R2e diluent vol 0 Analy.Methd. EPA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 2 Qualit. Judge Not do

Sample Vol (U) 2 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 0

Reagent 2e stir Weak M-DET.P.m 40

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 18

Sample Type Serum S-DET.P.r 19

Dilution specification Do Check D.P.I. 0

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 2 Reac.typ Inc.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Not Do

Diluent position 0 Blank (u) 9.999

Diluent volume from RPP 0,000 Blank (d) -9.999

Sample Type Urine Sample (u) 9.999

Dilution specification Do Sample (d) -9.999

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 2 Re.absorb (u) 9.999

Diluent method No dilution Re.absorb (d) -9.999

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 2 Serum reac.smp.vol (u) 2

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 10 Serum reac.smp.vol (u) 10

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

May 2009/2

APLICAÇÕES 1200

Proteína Urinária - Diasys

Analytical conditions

R1 volume 80.0 Sub Param. 46 - 1 Up Down Standards setting

R2 volume 0.00 Sub-analy-conditions BLK H 9.99999 Multi-STD Abnml (serum)H 300,0

R3 volume 0.00 Nam

e

PT u Digits 1 BLK-L -9.9999 Abnml (serum)L

Abnml (urine)H

0.0

300,0

R4 volume 0.00 H-wave.L. 596nm STD H 9.99999

R1 diluent vol 0.00 S-wave.L. ****nm STD L -9.9999

R2 diluent vol 0.00 Analy.mth

d

EPA FV ------ Normal value set

* 1

R3 diluent vol 0.00 Calc.

mthd

STD

R4 diluent vol 0.00

Qualit.jud

g

Not do Quality.set

Serum

reac.s.vol.

1,6 Real-time correct.

Form

CCalculation method setting

Serum dil.

method.

Reanalysis conditions M-DET.P.1 0 S-DETP.p. 0

Serum dil.s.vol. Serum reac.smp.vol.

(µ)

1,6 M-DET.P.m 20 S-DET.P.r 0 Reaction rate method

erum dil. volume Serum dilute.method

(µ)

Spe M-DET.P.n 21 Cycle 3

Serum dil. posit. 0 Serum dil.emp.vol. (µ) 15,0 Check D.P.I 0 Factor 3.0

Urine set Serum diluente vol (µ) 120,0 Limit value 0.003 Reac.typ Inc

Reaction time 10 min Serum diluent posi (µ) 0 Variance 10.0 E2 corre Not do

Reagent 1 stir Weak Serum reac.smp.vol (d) ----- * Prozone Blank(µ) 9.999

Reagent 2 stir Weak Serum dilut.method (d) ------- Prozone form None Blank(d) -9.9999

Reagent 3 stir Weak Serum dil.emp.vol.(d) ------ Prozone limit 9.999 Sample (µ) 9.999

Reagent 4 stir Weak Serum diluent vol (d) ------ Prozone judge Upper limit Sample (d) -9.9999

Serum diluent posi (d) 0 Judge limit 9.999 * Endpoint method

M-DET.P.m 0 S-DET.P.p 0 Re.absorb(µ) 9.9999

M-DET.P.n 0 S-DET.P.r 0 Re.absorb(d) -9.9999

Urine set Rerun.cond. IMA setting

Rendimento : 1184 testes

:

May 2009/2

ASAT(GOT) FS (IFCC mod.)

Cat. No 1 2601......... Notes 1. Please refer to the package insert for ASAT(GOT) FS (IFCC Mod.) for detailed information about the test on the

following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name ASAT

R2e volume 0 Digits 1

R2 volume 20 M-wave L. 340

R1 diluent vol 0 S-wave.L 410

R2e diluent vol 0 Analy.Methd. RRA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 8 Qualit. Judge Not do

Sample Vol (U) 8 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 22

Reagent 2e stir Weak M-DET.P.m 25

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 0

Sample Type Serum S-DET.P.r 0

Dilution specification Do Check D.P.I. 21

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 8 Reac.typ Dec.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Do

Diluent position 0 Blank (u) 2.000

Diluent volume from RPP 0,000 Blank (d) 0.721

Sample Type Urine Sample (u) 2.000

Dilution specification Do Sample (d) 0.690

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 8 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 8 Serum reac.smp.vol (u) 8

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 16 Serum reac.smp.vol (u) 16

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

May 2009/2

ALAT(GPT) FS (IFCC mod.)

Cat. No 1 2701......... Notes 1. Please refer to the package insert for ALAT(GPT) FS (IFCC Mod.) for detailed information about the test on the

following: Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 80 Name ALAT

R2e volume 0 Digits 1

R2 volume 20 M-wave L. 340

R1 diluent vol 0 S-wave.L 410

R2e diluent vol 0 Analy.Methd. RRA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 8 Qualit. Judge Not do

Sample Vol (U) 8 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 22

Reagent 2e stir Weak M-DET.P.m 25

Reagent 2 stir Weak M-DET.P.n 42

Reaction time 10 S-DET.P.p 0

Sample Type Serum S-DET.P.r 0

Dilution specification Do Check D.P.I. 21

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 8 Reac.typ Dec.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Do

Diluent position 0 Blank (u) 2.000

Diluent volume from RPP 0,000 Blank (d) 0.771

Sample Type Urine Sample (u) 2.000

Dilution specification Do Sample (d) 0.690

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 8 Re.absorb (u)

Diluent method No dilution Re.absorb (d)

Undiluted sample volume 0 Rerun conditions set

Diluent volume 0,000 Absorbance limit (u) D1

Diluent position 0 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 8 Serum reac.smp.vol (u) 8

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 20

Diluent volume 40 Diluent volume 40

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 16 Serum reac.smp.vol (u) 16

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)

APLICAÇÕES Advia 1200

TRIGLICÉRIDES DIASYS

Analytical conditions

R1 volume 100.0 Sub Param. 46 1 Up Down

R2e volume 0.00 Sub-analy-conditions Standards setting

R3 volume 0.00 Name Trig FV *** BLK-L -9.999 STD H -9.999 Multi-STD Setting

Digits 0 BLK-H 9.9999 STD L 9.9999 Error judge rare

R1 Extra vol H-wave.L. 505nm

R2 Extra vol S-wave.L. 694nm

R3 Extra vol Anal.mthd EPA

R1 diluent vol 0.00 Calc.mthd STD

R2e diluent vol 0.00

Quali.judg Not do

R3 diluent vol 0.00 CCalculation method setting

Sample Vol( S ) 1,0 M-DET.P.1 0 S-DETP.p. 0 Reac.typ Inc

Sample vol (U) 1,0 Qualit. Judgment set M-DET.P.m 19 S-DET.P.r 0 Reaction rate method

Real time correct form M-DET.P.n 20 Cycle 2

Reanalysis conditions Check D.P.I 0 Factor 2.0

Rerun conditions set Limit value 0.003 E2 corre Not do

Reagent 1 stir Weak Mark setting Variance 10.0 Blank(µ) 9.9999

Reagent 2e stir Weak Normal Value setting * Prozone Blank(d) -9.9999

Reagent 2 stir Weak Abnormal value setting Prozone form None Sample(µ) 9.9999

Reaction Time 10 min. Prozone limit 9.999 Sample

(d)

9.9999

Prozone judge Upper limit

Anaysis item

Condition setting (M)

Judge limit 9.999 * Endpoint method

M-DET.P.m 0 S-DET.P.p 0 Re.absorb(µ) 9.9999

M-DET.P.n 0 S-DET.P.r 0 Re.absorb(d) -9.9999

IMA setting

Setting

Allowance

Metodologia: Colorimétrico Enzimático - GOP

Valor de Referência: Desejável: < 200 mg/dL

Limite alto: 200 a 400 mg/dL

Elevado: > 400 mg/dL

Linearidade: 1000 mg/dL

Apresentação : 5 x 25 mL Rendimento 1014 Testes

May 2009/2

UREA FS

Cat. No 1 3101.........

Notes 1. Please refer to the package insert for Urea FS for detailed information about the test on the following:

Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

Analytical conditions Sub-analy. conditions

R1 volume 100 Name UREA

R2e volume 0 Digits 1

R2 volume 25 M-wave L. 340

R1 diluent vol 0 S-wave.L 410

R2e diluent vol 0 Analy.Methd. RRA

R2 diluent vol 0 Calc.Methd. STD

Sample Vol (S) 1.2 Qualit. Judge Not do

Sample Vol (U) 1.2 Calculation method setting

Reagent 1 stir Weak M-DET.P.l 21

Reagent 2e stir Weak M-DET.P.m 24

Reagent 2 stir Weak M-DET.P.n 31

Reaction time 10 S-DET.P.p 0

Sample Type Serum S-DET.P.r 0

Dilution specification Do Check D.P.I. 21

Dilution correction Not Do Limit value 0,003

Liquid volume correction Not Do Variance 10

Reaction sample volume 5 Reac.typ Dec.

Diluent method No dilution Cykle 2

Undiluted sample volume 0 Factor 2

Diluent volume 0,000 E2 corr Do

Diluent position 0 Blank (u) 9.999

Diluent volume from RPP 0,000 Blank (d) -9.999

Sample Type Urine Sample (u) 9.999

Dilution specification Do Sample (d) -9.999

Dilution correction Do

Liquid volume correction Do Endpoint method

Reaction sample volume 1.2 Re.absorb (u) 10.000

Diluent method A dilution Re.absorb (d) -9.999

Undiluted sample volume 2 Rerun conditions set

Diluent volume 248 Absorbance limit (u) D1

Diluent position 1 Absorbance limit (d) D2

Diluent volume from RPP 0,000 Effect.nbr.o.pnts (n)

Abnormal val.limit (h) D1

Abnormal val.limit (l) D2

Reanalysis conditions

Sample Type Serum Sample Type Urine

Dilute 1 Dilute 1

Serum reac.smp.vol (u) 1.2 Serum reac.smp.vol (u) 1.2

Dilution method A dilution Dilution method A dilution

Undiluted sample volume 20 Undiluted sample volume 2

Diluent volume 40 Diluent volume 248

Diluent position 1 Diluent position 1

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Dilute 2 Dilute 2

Serum reac.smp.vol (u) 1.2 Serum reac.smp.vol (u) 1.2

Dilution method No dilution Dilution method No dilution

Undiluted sample volume 0 Undiluted sample volume 0

Diluent volume 0 Diluent volume 0

Diluent position 0 Diluent position 0

Diluent volume from RPP 0,000 Diluent volume from RPP 0,000

Abnormal value setting

Main Abnormal value (H1)

Main Abnormal value (L1)