program 2: chemistry parameters order information notes€¦ · 10 040 021 r1 5 x 20 ml + r2 1 x 25...

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845 4201 704 July 2001/2 HITACHI 704 Chemistry settings Temperature: 37 °C PROGRAM 2: CHEMISTRY PARAMETERS TEST ALP ASSAY CODE 5 – 19 - 32 SAMPLE VOLUME (μl) 5 R1 VOLUME (μl) 280 – 50 - 0 R2 VOLUME (μl) 70 – 20 - 0 WAVELENGTH (nm) 660 - 415 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 0 STD. 2 CONC.-POS. 0 – 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/l SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 10000 - 0 PROZONE LIMIT 0 EXPECTED VALUE 0 - 258 INSTRUMENT FACTOR 1.0 #) Data entry by the user *) Enter calibration or standard value and position **) Factor must be checked by a calibration serum ALKALINE PHOSPHATASE FS DGKC Order information Cat. No. Kit size 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200 ml 10 040 704 R1 8 x 50 ml + R2 8 x 12.5 ml Notes 1. Please refer to the package insert for Alkaline phosphatase 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 & Co.KG Alte Strasse 9, 65558 Holzheim, Germany

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Page 1: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 4201 704

July 2001/2

HITACHI 704 Chemistry settings Temperature: 37 °C PROGRAM 2: CHEMISTRY PARAMETERS

TEST ALP ASSAY CODE 5 – 19 - 32 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 280 – 50 - 0 R2 VOLUME (µl) 70 – 20 - 0 WAVELENGTH (nm) 660 - 415 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 0 STD. 2 CONC.-POS. 0 – 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/l SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 10000 - 0 PROZONE LIMIT 0 EXPECTED VALUE 0 - 258 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

**) Factor must be checked by a calibration serum

ALKALINE PHOSPHATASE FS DGKC Order information Cat. No. Kit size 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml

10 040 022 R1 5 x 80 ml + R2 1 x 100 ml

10 040 023 R1 1 x 800 ml + R2 1 x 200 ml

10 040 704 R1 8 x 50 ml + R2 8 x 12.5 ml Notes 1. Please refer to the package insert for

Alkaline phosphatase 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 & Co.KG Alte Strasse 9, 65558 Holzheim, Germany

Page 2: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 1200 704

July 2001/2

HITACHI 704 Chemistry settings Temperature: 37 °C PROGRAM 2: CHEMISTRY PARAMETERS

TEST CL ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 –20 – NO WAVELENGTH (nm) 600 – 480 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MMOL/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 95 – 105 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

CHLORIDE FS Order information Cat. No. Kit size 10 120 021 R 5 x 25 ml + 1 x 3 ml Std

1 1200 99 10 026 R 6 x 100 ml

10 120 023 R 1 x 1000 ml

10 120 0030 6 x 3 ml Standard

10 120 704 R 8 x 50 ml Notes 1. Please refer to the package insert for Chloride 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 & Co.KG Alte Strasse 9, 65558 Holzheim, Germany

Page 3: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 1200 704

July 2001/2

Page 4: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 2521 704

July 2001/2

HITACHI 704 Chemistry settings Temperature: 37 °C PROGRAM 2: CHEMISTRY PARAMETERS

TEST GLUC ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 70 – 115 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

GLUCOSE HEXOKINASE FS Order information Cat. No. Kit size 10 251 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3ml Std

1 2511 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

10 251 023 R1 1 x 800 ml + R2 1 x 200 ml

10 250 030 6 x 3 ml Standard

10 251 704 R1 8 x 50 ml + R2 8 x 12.5 ml Notes 1. Please refer to the package insert for Glucose Hexokinase 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 & Co.KG Alte Strasse 9, 65558 Holzheim, Germany

Page 5: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 2521 704

July 2001/2

Page 6: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 3001 704

July 2001/2

HITACHI 704 Chemistry settings Temperature: 37 °C PROGRAM 2: CHEMISTRY PARAMETERS

TEST UA ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 546 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 2.3 – 8.2 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

URIC ACID FS TOOS Order information Cat. No. Kit size 10 300 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml Std

1 3001 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

10 300 023 R1 1 x 800 ml + R2 1 x 200 ml

10 300 030 6 x 3 ml Standard

10 300 704 R1 8 x 50 ml + R2 8 x 12.5 ml Notes 1. Please refer to the package insert for Uric Acid FS TOOS 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 & Co.KG Alte Strasse 9, 65558 Holzheim, Germany

Page 7: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 3001 704

July 2001/2

Page 8: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 3021 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST UA ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT mg/dl SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 2.3 – 8.2 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

URIC ACID FS TBHBA Order information

Cat. No. 1 3021 .. .. …

Notes

1. Please refer to the package insert for Uric Acid 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 was set up and evaluated at 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.

Page 9: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 0220 10 02 01

September 2006/4

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST ALB ASSAY CODE 1 – 7 – 0 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 50 – NO WAVELENGTH (nm) 700 – 600 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * – 2 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT G / DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 3.5 – 5.2 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

ALBUMIN FS Order information

Cat. No. 1 0220 .. .. …

Notes

1. Please refer to the package insert for Albumin 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 at 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.

Page 10: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 0501 10 02 01

March 2007/5

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST AMYL ASSAY CODE 5 – 25 - 31 SAMPLE VOLUME (µl) 7 R1 VOLUME (µl) 280 – 50 – 0 R2 VOLUME (µl) 70 – 20 – 0 WAVELENGTH (nm) 660 – 415 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/l SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 11000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE # - # INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

**) Factor must be checked by a calibration serum

-AMYLASE CC FS

Order information

Cat. No. 1 0501 .. .. …

Notes

1. Please refer to the package insert for -Amylase CC 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 was set up and evaluated at 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.

Page 11: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 7102 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST APOA ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 20 – 0 R2 VOLUME (µl) 70 – 20 – 0 WAVELENGTH (nm) 0 – 570 CALIBR. METHOD 3 – 1 – 4 STD. 1 CONC.-POS. 0 - 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. * - * STD. 4 CONC.-POS. * - * STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 999 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 - 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 110 - 190 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

APOLIPOPROTEIN A1 FS Order information

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 was set up and evaluated at 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.

Page 12: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 7112 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST APOB ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350 – 20 – 0 R2 VOLUME (µl) 70 – 20 – 0 WAVELENGTH (nm) 0 – 340 CALIBR. METHOD 3 – 1 – 4 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. * - * STD. 4 CONC.-POS. * - * STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 - 0 UNIT MG/DL SD LIMIT 999 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 75 – 155 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

APOLIPOPROTEIN B FS Order information

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 was set up and evaluated at 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.

Page 13: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

846 0950 10 02 01

September 2006/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST CO2 ASSAY CODE 2 – 4 – 25 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 50 – NO WAVELENGTH (nm) 505 – 415 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MMOL/L SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 1 PROZONE LIMIT -32000 – 0 EXPECTED VALUE 22 – 29 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

BICARBONATE FS Order information

Cat. No. 1 0950 .. .. …

Notes

1. Please refer to the package insert for 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 3 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 at 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.

Page 14: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 0821 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST BIDI ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 320 – 50 – 0 R2 VOLUME (µl) 80 – 20 – 0 WAVELENGTH (nm) 660 – 546 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 - 0 EXPECTED VALUE 0.0 – 0.2 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

BILIRUBIN AUTO DIRECT FS

Order information

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 was set up and evaluated at 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.

Page 15: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 0811 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST BILI ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 10 R1 VOLUME (µl) 320 – 50 – 0 R2 VOLUME (µl) 80 – 20 – 0 WAVELENGTH (nm) 660 - 546 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 - 0 PROZONE LIMIT 0 - 0 EXPECTED VALUE 0.1 – 1.2 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

BILIRUBIN AUTO TOTAL FS

Order information

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 was set up and evaluated at 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.

Page 16: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

846 1130 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST CALC ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 50 – NO WAVELENGTH (nm) 700 – 660 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 8.6 – 10.3 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

CALCIUM AS FS Order information

Cat. No. 1 1130 .. .. …

Notes

1. Please refer to the package insert for Calcium AS 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 at 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.

Page 17: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 1651 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST CKMB ASSAY CODE 5 – 25 – 32 SAMPLE VOLUME (µl) 13 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 9000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 24 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

**) Factor must be checked by a calibration serum

CK-MB FS Order information

Cat. No. 1 1651 .. .. …

Notes

1. Please refer to the package insert for CK-MB 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 was set up and evaluated at 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.

Page 18: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 1601 10 02 01

April 2003/4

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST CK ASSAY CODE 5 – 22 – 32 SAMPLE VOLUME (µl) 10 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 9000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

**) Factor must be checked by a calibration serum

CK-NAC FS Order information

Cat. No. 1 1601 .. .. …

Notes

1. Please refer to the package insert for CK-NAC 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 was set up and evaluated at 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.

Page 19: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 1200 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST CL ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 –20 – NO WAVELENGTH (nm) 600 – 480 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MMOL/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 95 – 105 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

CHLORIDE FS Order information

Cat. No. 1 1200 .. .. …

Notes

1. Please refer to the package insert for Chloride 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 7 days

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 at 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.

Page 20: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 1300 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST CHOL ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 20 – NO WAVELENGTH (nm) 700 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 200 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

CHOLESTEROL FS Order information

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 was set up and evaluated at 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.

Page 21: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 1401 10 02 01

September 2006/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST CHE ASSAY CODE 5 – 21 – 30 SAMPLE VOLUME (µl) 6 R1 VOLUME (µl) 300 – 50 – NO R2 VOLUME (µl) 75 – 20 – NO WAVELENGTH (nm) – 415 CALIBR. METHOD 2** – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 1 PROZONE LIMIT 0 – 0 EXPECTED VALUE 3930 – 11500 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

**) Factor must be checked by a calibration serum

CHOLINESTERASE FS Order information

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 8 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 at 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.

Page 22: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 1711 10 02 01

March 2008/5

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST CREA ASSAY CODE 5 – 19 – 23 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 570 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 5500 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0.6 – 1.3 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

CREATININE FS Order information

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 4 days

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 at 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.

Page 23: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 1711 10 02 01

March 2008/5

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST CREA ASSAY CODE 5 – 19 – 23 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 570 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 5500 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0.6 – 1.3 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

CREATININE FS

Compensated Method

To use the Creatinine Compensated Method on the Hitachi 704 go to Parameter Job, Chapter 7, Compensated Test and input the following formula; When the units are mg/dL [ (Crea test Code) ] [ - ] [ 0.3 ] [ ; ] When the units are µmol/L [ (Crea test Code) ] [ - ] [ 27 ] [ ; ] Note: Ensure that when using the Creatinine Compensated Method the relevant assigned Calibrator value is selected

Page 24: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 1759 10 02 53October 2008/3

COBAS MIRA Plus

Instrument settingsTest name:CREATemperature: 37 °C

GENERALMEASUREMENT MODE: ABSORB [1]REACTION MODE: R –S – SR1 [3]CALIBRATION MODE: SLOPE AVG [2]REAGENT BLANK: REAG / DIL [2]CLEANER: NO [1]WAVELENGTH: 550 nm [4]DECIMAL POSITION: 21UNIT: 12 (mg/ dl) or 04 (µmol/l)

ANALYSISPOST DIL. FACTOR: [2]CONC. FACTOR: NO [SPACE]SAMPLE CYCLE: [1]VOLUME: 6 µlDILUTION NAME: H2O [00]

VOLUME: 10 µlREAGENT CYCLE: 1VOLUME: 150 µlSTART R 1 CYCLE: 10VOLUME: 75 µlDILUTION NAME: [00]VOLUME: 10 µl

CALCULATIONSAMPLE LIMIT: NO [SPACE]POINT:REAC. DIRECTION: INCREASE [1]CHECK: ON [1]CONVERS. FACTOR: 1OFFSET: 0TEST RANGE LOW: 0 (mg/dl) or 0 (µmol/l)

HIGH: 17.3 (mg/dl) or 1500 (µmol/l)NORM. RANGE LOW: 0.5 (mg/dl) or 44 (µmol/l)

HIGH: 1.1 (mg/dl) or 97 (µmol/l)NUMBER OF STEPS: 1CALC. STEP A: ENDPOINT [1]READINGS FIRST: 11

LAST: 25REACTION LIMIT:POINT:

CALIBRATIONCALIBRATION INTERVAL: EACH DAY [2]TIME: NO [SPACE]BLANK:REAG. RANGE LOW: NO [SPACE]

HIGH: NO [SPACE]BLANK RANGE LOW: NO [SPACE]

HIGH: NO [SPACE]FACTOR:

STANDARD POS: # .....STD.-1: Calibrator value *....STD.-2: NO [SPACE]STD.-3: NO [SPACE]

REPLICATE: DUPL [1]DEVIATION: 10%

CONTROLCS 1 POS: Low:..... Assign:.... High:........CS 2 POS: Low:..... Assign:.... High:........CS 3 POS Low:..... Assign:.... High:........#) Data entry by the user*) Enter calibration or standard value and position**) The factor must be checked by a calibration serum.

CREATININE PAP FS

Order information

Cat. No. 1 1759 .. .. …

Notes

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

Clinical RelevanceMethod and PrincipleComposition and Stability of the ReagentsSpecimensCalibrators and ControlsPerformance Characteristics regarding

- Measuring Range- Specificity/Interferences- Sensitivity/Limit of Detection- Precision (Reproducibility, Repeatability)- Method Comparison

Reference RangesLiterature

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

3. Manufactured byDiaSys Diagnostic Systems GmbHAlte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoidmisinterpretation measured results have to be validated andassessed with caution

Page 25: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 7059 10 02 01

April 2004/4

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST FERR ASSAY CODE 2 – 18 – 32 SAMPLE VOLUME (µl) 12 R1 VOLUME (µl) 240 – 20 – NO R2 VOLUME (µl) 120 – 20 – NO WAVELENGTH (nm) – 570 CALIBR. METHOD 3 – 4 – 5 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. * – * STD. 4 CONC.-POS. * – * STD. 5 CONC.-POS. * – * STD. 6 CONC.-POS. 0 – 0 UNIT µG/L SD LIMIT 999 DUPLICATE LIMIT 32000 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT -32000 – 0 EXPECTED VALUE 30 – 300 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

FERRITIN FS Order information 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 was set up and evaluated at 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.

Page 26: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 1911 10 02 01

September 2006/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST FE ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 600 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT UG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 23 – 168 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

IRON FS Ferene Order information

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 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 at 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.

Page 27: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 0411 10 02 01

September 2006/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST ALP ASSAY CODE 5 – 19 - 32 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 280 – 50 – 0 R2 VOLUME (µl) 70 – 20 – 0 WAVELENGTH (nm) 660 - 415 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 0 STD. 2 CONC.-POS. 0 – 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/l SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 12000 – 0 PROZONE LIMIT 0 EXPECTED VALUE # - # INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

**) Factor must be checked by a calibration serum

ALKALINE PHOSPHATASE FS IFCC 37° C

Order information

Cat. No. 1 0441 .. .. …

Notes

1. Please refer to the package insert for

Alkaline phosphatase IFCC 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 8 days

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 at 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.

Page 28: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 5211 10 02 01

January 2005/2

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST PHOS ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 0 – 340 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 1.8 – 4.5 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

PHOSPHATE FS Order information

Cat. No. 1 5211 .. .. …

Notes

1. Please refer to the package insert for Phosphate 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

Page 29: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 2801 10 02 01

April 2003/4

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST GGT ASSAY CODE 5 – 19 – 32 SAMPLE VOLUME (µl) 10 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 660 – 415 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 5500 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

**) Factor must be checked by a calibration serum

GAMMA GT FS (Szasz mod.) Order information

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 was set up and evaluated at 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.

Page 30: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 2500 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST GLUC ASSAY CODE 1 – 32 - 0 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 - NO R2 VOLUME (µl) 0 – 20 - NO WAVELENGTH (nm) 700 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 - 0 EXPECTED VALUE 70 - 115 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

GLUCOSE GOD FS Order information

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 was set up and evaluated at 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.

Page 31: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 3329 10 02 01

January 2010/5

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST HbA1c ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 6 R1 VOLUME (µl) 240 – 20 – 0 R2 VOLUME (µl) 120 – 20 – 0 WAVELENGTH (nm) 0 - 660 CALIBR. METHOD 3 – 4 – 5** STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * – * STD. 3 CONC.-POS. * – * STD. 4 CONC.-POS. * – * STD. 5 CONC.-POS. * – * STD. 6 CONC.-POS. 0 – 0 UNIT # SD LIMIT 999 DUPLICATE LIMIT 10000 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 32000 - 0 PROZONE LIMIT -32000 - 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position **) Spline function

oneHbA1c FS Order information

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

30 days 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 at 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.

Page 32: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 3521 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST HDL ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 600 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 35 – 80 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

HDL-C IMMUNO FS Order information

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 was set up and evaluated at 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.

Page 33: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 4001 10 02 01

September 2006/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST LAC ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 320 – 50 – 0 R2 VOLUME (µl) 80 – 20 – 0 WAVELENGTH (nm) 700 - 340 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 - 0 PROZONE LIMIT 0 - 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

LACTATE FS Order information

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 5 days

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 at 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.

Page 34: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 4201 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST LDH ASSAY CODE 5 – 19 – 28 SAMPLE VOLUME (µl) 7 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 6500 – 1 PROZONE LIMIT 0 – 0 EXPECTED VALUE 225 – 480 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

**) Factor must be checked by a calibration serum

LDH FS DGKC

Order information

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 Alte Strasse 9, 65558 Holzheim, Germany

**This application was set up and evaluated at 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.

Page 35: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 4121 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST LDL ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 320 – 20 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 600 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 130 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

LDL-C SELECT FS Order information

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 was set up and evaluated at 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.

Page 36: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 4321 10 02 01 September 2006/4

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST LIP ASSAY CODE 5 – 21 – 25 SAMPLE VOLUME (µl) 7 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 570 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - 2 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 32000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 60 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

**) Factor must be checked by a calibration serum

LIPASE DC FS Order information

Cat. No. 1 4321 .. .. …

Notes

1. Please refer to the package insert for Lipase DC 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 at 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.

Page 37: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 7139 10 02 01

August 2007/2

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST LPA ASSAY CODE 2 – 19 – 31 SAMPLE VOLUME (µl) 6 R1 VOLUME (µl) 240 – 20 – NO R2 VOLUME (µl) 120 – 20 – NO WAVELENGTH (nm) 0 – 700 CALIBR. METHOD 3 – 1 – 4 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. * – * STD. 4 CONC.-POS. * – * STD. 5 CONC.-POS. * – * STD. 6 CONC.-POS. * – * UNIT MG/DL SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 0 – 30 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

Lp(a) 21 FS

Order information

Cat. No. 1 7139 .. .. …

Notes

1. Please refer to the package insert for Lp(a) 21 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 3 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 at 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.

Page 38: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 4610 10 02 01

September 2006/4

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST MAG ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 50 – NO WAVELENGTH (nm) 700 – 546 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - 2 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 1.8 – 2.6 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

MAGNESIUM XL FS Order information

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 3 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 at 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.

Page 39: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 7045 10 02 01

November 2008/1

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST CRP ASSAY CODE 2 – 18 – 32 SAMPLE VOLUME (µl) 18 R1 VOLUME (µl) 180 – 20 – NO R2 VOLUME (µl) 180 – 20 – NO WAVELENGTH (nm) – 505 CALIBR. METHOD 3 – 1 – 6 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. * – * STD. 4 CONC.-POS. * – * STD. 5 CONC.-POS. * – * STD. 6 CONC.-POS. * – * UNIT mg/L SD LIMIT 999 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 0 – 5 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

CRP U-hs High sensitive (hs) application

Order information 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.

Page 40: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 2311 10 02 01

September 2006/4

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST TP ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 7 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 0 – 546 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT G/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 6.6 – 8.8 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

TOTAL PROTEIN FS Order information

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 10 days

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 at 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.

Page 41: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 0210 10 52 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST TPU ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 6 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 20 – NO WAVELENGTH (nm) 700 – 600 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/L SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

TOTAL PROTEIN UC FS Order information

Cat. No. 1 0210 .. .. …

Notes

1. Please refer to the package insert for Total Protein UC 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 was set up and evaluated at 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.

Page 42: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 2601 10 02 01

April 2003/4

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST GOT ASSAY CODE 5 – 20 – 32 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 6000 – 1 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

**) Factor must be checked by a calibration serum

ASAT(GOT) FS (IFCC mod.)

Order information

Cat. No. 1 2601 .. .. …

Notes

1. Please refer to the package insert for

ASAT(GOT) FS (IFCC Mod) for the 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 was set up and evaluated at 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.

Page 43: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 2701 10 02 01

April 2003/4

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST GPT ASSAY CODE 5 – 20 – 32 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 6000 – 1 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

**) Factor must be checked by a calibration serum

ALAT(GPT) FS (IFCC mod.)

Order information

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 was set up and evaluated at 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.

Page 44: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 5710 10 02 01

July 2001/3

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST TRIG ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 20 – NO WAVELENGTH (nm) 700 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 200 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

TRIGLYCERIDES FS Order information

Cat. No. 1 5710 .. .. …

Notes

1. Please refer to the package insert for Triglycerides 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 was set up and evaluated at 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.

Page 45: PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml 10 040 022 R1 5 x 80 ml + R2 1 x 100 ml 10 040 023 R1 1 x 800 ml + R2 1 x 200

845 3101 10 02 01

September 2006/4

HITACHI 704 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS

TEST UREA ASSAY CODE 5 – 19 – 22 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 6000 – 1 PROZONE LIMIT 0 – 0 EXPECTED VALUE 17 – 43 INSTRUMENT FACTOR 1.0

#) Data entry by the user *) Enter calibration or standard value and position

UREA FS Order information

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 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 at 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.