cholinesterase fs hitachi 717 - grupo biosys · hitachi 717 chemistry settings temperature: ......

845 1401 10 02 03

February 2004/1

HITACHI 717 Chemistry settings Temperature: 37 °C

PROGRAM 2: CHEMISTRY PARAMETERS TEST CHE ASSAY CODE 5 – 30 – 50 SAMPLE VOLUME (µl) 4 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 0 – 405 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 1 PROZONE LIMIT 0 EXPECTED VALUE 3930 – 11500 PANIC VALUE 0 - 25000 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 at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

845 2701 10 02 10 October 2009/3

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 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.

HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST GPT ASSAY CODE 5 – 30 – 50 SAMPLE VOLUME (µl) 15 R 1 VOLUME (µl) 200 – 20 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 405 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 6000 – 1 PROZONE LIMIT 0 EXPECTED VALUE # – # PANIC VALUE 0 - 600 INSTRUMENT FACTOR 1.0

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

**) Factor must be checked by a calibration serum

HITACHI 912 – CHEMISTRY PARAMETERS Analysis

TEST [ALAT] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [ALAT] ASSAY/TIME/POINTS [Rate A] [10] [20] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [415] [340]

SAMPLE VOLUME CLASS 1 CLASS 2 REAGENT NORMAL [15] [0] [0] [1] [0] [0] R1 [200] [0] [00108] [#]

DECREASE [7] [0] [0] [1] [0] [0] R2 [0] [0] [00108] [#] INCREASE [25] [0] [0] [1] [0] [0] R3 [50] [0] [00108] [#]

CLASS 1 CLASS 2 DECR./INCR. R4 [0] [0] [00108] [#] ABSORBANCE LIMIT [6000] [0] [decrease] TWINTEST [ ]

PROZONE LIMIT [0] [0] [lower] Calibration

TEST [ALAT] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]

WEIGHT [0] AUTOMATIC CALIBRATION

AUTO TIME OUT AUTO CHANGE BLANK [0] St LOT [ ] SD LIMIT [0.1] SPAN [0] St BOTTLE [ ] DUPLICATE LIMIT [10] % [200] ABS

2-POINT [0] St SENSITIVITY LIMIT [-99999] - [99999] FULL [0] St S1 ABS LIMIT [-32000] - [32000]

Range TEST [ALAT] REPORT NAME [ALAT] DATA MODE [Aktiv]

TEST NAME [ALAT] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]

SAMPLE TYPE [Ser/Pl] Reference ranges and technical limits: entry by user / see package insert Standards

TEST [ALAT] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]

CONCENTRATION # # POSITION # #

SAMPLE VOLUME [15] [15] [1] [1] [1] [1]

DIL. SAMPLE VOLUME [0] [0] [0] [0] [0] [0] DILUENT VOLUME [0] [0] [0] [0] [0] [0]

#) data entry by the user *) enter calibration or standard value and position

845 2701 10 02 10 October 2009/3

BM / HITACHI 911

04-01 CHEMISTRY PARAMETERS

TEST ALAT # TEST NAME ALAT UNIT U/L

DATA MODE ON BOARD REPORT NAME ALAT

CONTROL INT 0 INSTR. FACT. (Y=aX + b) a 1.0

b 0.0

EXPECTED VALUE CLASS 1 EXPECTED VALUE CLASS 2

AGE M F

- -

- -

# - # # - #

TECHNICAL LIMIT CLASS I CLASS 2

0 - 600 -

STD CON POS S.VOL

.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 15 0 0 # (1)

(2) * # 15 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST ALAT

ASSAY CODE Rate A 10 WAVELGTH (SUB / MAIN)

415 / 340

ASSAY POINTS 20 - 31- 0 - 0 DILUTION 301 99

< CLASS 1 > < CLASS 2 >

S.VOL (NORMAL) 15 0 0

S. VOL (DECREASE) 7 0 0

S.VOL (INCREASE) 25 0 0

ABS. LIMIT 6000] 1:DECREASE

PROZONE LIMIT 0 LOWER

REAGENT R1 200 0 108 #

R2 0 0 108 #

R3 50 0 108 #

R4 0 0 108 #

CALIB. TYPE [1:LINEAR] 2 2 0

AUTOCALIB.

TIME OUT BLANK 0 SD LIMIT 0.1

SPAN 0 DUPLICATE LIMIT 200

2 POINT 0 SENSITIVITY LIMIT 0

FULL 0 SI ABS. LIMIT -3200032000

CHANGE LOT NO COMPENSATED LIMIT

BOTTLE NO

# Data entry by the user * Enter calibration or standard value ** The given factor must be checked by a calibratior ## Enter the next code

BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name GPT 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 415 10 Wave Leng. (MAIN) 340 11 Sample Volume 15 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 6000 50 ABS Limit (D/I) Decrease 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 42 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #

#) Data entry by the user *) Calculated by the analyzer

845 0220 10 02 10 September 2006/3

ALBUMIN FS Cat. No 1 0220.........

Notes 1. Please refer to the package insert 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.


HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST ALB ASSAY CODE 1 – 8 – 0 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 350 – 100 – No R 2 VOLUME (µl) 0 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 EXPECTED VALUE 3.5 – 5.2 PANIC VALUE 0.2 – 6.0 INSTRUMENT FACTOR 1.0



TEST [ALB] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [ALB] ASSAY/TIME/POINTS [1 point] [10] [6] [0] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [660]



CLASS 1 CLASS 2 DECR./INCR. R4 [0] [0] [00377] [#] ABSORBANCE LIMIT [0] [0] [increase] TWINTEST [ ]

PROZONE LIMIT [32000] [0] [higher] Calibration

TEST [ALB] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [ALB] REPORT NAME [Albumin] DATA MODE [Aktiv]

TEST NAME [ALB] [] CONTROL INTERVAL UNIT [g/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [ALB] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [2] [2] [1] [1] [1] [1]



845 0220 10 02 10 September 2006/3

BM / HITACHI 911


TEST ALB # TEST NAME ALB UNIT g/dl

DATA MODE ON BOARD REPORT NAME Albumin


b 0.0


AGE M F

- -

- -

3.5 - 5.2 3.5 - 5.2


0.2 - 6.0 -

STD CON POS S.VOL PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 2 0 0 # (1)

(2) * # 2 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST ALB

ASSAY CODE 1 point 3 WAVELGTH (SUB / MAIN)

700 / 660

ASSAY POINTS 6 - 0 - 0 - 0 DILUTION 301 99





ABS. LIMIT 0 2:INCREASE

PROZONE LIMIT 32000 1:HIGHER

REAGENT R1 250 0 377 #

R2 0 0 377 #

R3 0 0 377 #

R4 0 0 377 #


AUTOCALIB.






BOTTLE NO

# Data entry by the user * Enter calibration or standard value ## Enter the next code

BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name ALB 2 Assay Code (Mthd) 1 Point 3 Assay Code (2. Test) 0 4 Reaction Time 5 5 Assay Point 1 10 6 Assay Point 2 0 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 600 11 Sample Volume 2.5 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 0 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 3.5 55 Expect. Value (H) 5.0 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 0242 10 02 10 August 2008/3

ALBUMIN IN URINE CSF/FS (Microalbumin) Serum application

Cat. No 1 0242.........

Notes 1. Please refer to the package insert for Albumin in

Urine/CSF FS *Microalbumin 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


at least one month provided that contamination and evaporation are avoided.




HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST S-ALB ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 3** R 1 VOLUME (µl) 350 – 20 – NO R 2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 0– 570 CALIBR. METHOD 3 – 4 – 6 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. * - * STD.3 CONC.-POS. * – * STD.4 CONC.-POS. * – * STD.5 CONC.-POS. * – * STD.6 CONC.-POS. * – * SD LIMIT 999.9 DUPLICATE LIMIT 10000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 0 – # PANIC VALUE # – # INSTRUMENT FACTOR 1.0


**) For Hitachi 717 calibrators, controls and samples must be prediluted 1+20 before analysing


TEST [S-Alb] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [S-Alb] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [570]





TEST [S-Alb] CALIBRATION TYPE [Spline] [ ]

CALIBRATION POINTS

[6] SPAN POINT [6]


AUTO TIME OUT AUTO CHANGE BLANK [0] St LOT [ ] SD LIMIT [999] SPAN [0] St BOTTLE [ ] DUPLICATE LIMIT [15] % [500] ABS


Range TEST [S-Alb] REPORT NAME [S-Alb] DATA MODE [Aktiv]

TEST NAME [S-Alb] [] CONTROL INTERVAL UNIT [g/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [S-Alb] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [#]

CONCENTRATION # # # # # # POSITION # # # # # #

SAMPLE VOLUME [10] [10] [10] [10] [10] [10]



845 0242 10 02 10 August 2008/3

BM / HITACHI 911


TEST S-Alb # TEST NAME S-ALB UNIT g/l

DATA MODE ON BOARD REPORT NAME ALBUMIN


b 0.0


AGE M F

- -

- -

# - # # - #


- -

STD CON POS S.VOL. PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 10 2 190 # (1)

(2) * # 10 2 190 # (2)

(3) * # 10 2 190 (3)

(4) * [# 10 2 190 (4)

(5) * # 10 2 190 (5)

(6) * # 10 2 190 (6)

TEST S-Alb

ASSAY CODE 2 Point end 10 WAVELGTH (SUB / MAIN)

/ 570






ABS. LIMIT 0 INCREASE

PROZONE LIMIT 32000 UPPER

REAGENT R1 250 0 005 #

R2 0 0 005 #

R3 50 0 005 #

R4 0 0 005 #

CALIB. TYPE [6: Spline] 6 6 0

AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name S-ALB 2 Assay Code (Mthd) 2 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 0 10 Wave Leng. (MAIN) 570 11 Sample Volume 3** 12 R1 VOLUME 350 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #

#) Data entry by the user *) Calculated by the analyzer **) For Hitachi 902 calibrators, controls and samples

must be prediluted 1+20 before analysing

845 0242 10 52 10 August 2008/4

ALBUMIN IN URINE/CSF FS (Microalbumin) Urine/CSF application Cat. No 1 0242.........

Notes 1. Please refer to the package insert for Albumin in

Urine/CSF FS *Microalbumin 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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST M-ALB ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 12 R 1 VOLUME (µl) 250 – 20 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 700 – 405 CALIBR. METHOD 3 – 4 – 6 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. * - * STD.3 CONC.-POS. * – * STD.4 CONC.-POS. * – * STD.5 CONC.-POS. * – * STD.6 CONC.-POS. * – * SD LIMIT 999.9 DUPLICATE LIMIT 10000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 0 – # PANIC VALUE 3 – 350 INSTRUMENT FACTOR 1.0



TEST [M-Alb] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [M-Alb] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [800] [415]





TEST [M-Alb] CALIBRATION TYPE [Spline] [ ]

CALIBRATION POINTS

[6] SPAN POINT [6]




Range TEST [M-Alb] REPORT NAME [M-Alb] DATA MODE [Aktiv]

TEST NAME [M-Alb] [] CONTROL INTERVAL UNIT [mg/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [M-Alb] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [#]


SAMPLE VOLUME [12] [12] [12] [12] [12] [12]



845 0242 10 52 10 August 2008/4

BM / HITACHI 911


TEST M-Alb # TEST NAME M-ALB UNIT mg/l

DATA MODE ON BOARD REPORT NAME MICROALBUMIN


b 0.0


AGE M F

- -

- -

22 - 29 22 - 29


- -


LOT

QUALITATIVE

NO

(1) 0.0 # 12 0 0 # (1)

(2) * # 12 0 0 # (2)

(3) * # 12 (3)

(4) * [# 12 (4)

(5) * # 12 (5)

(6) * # 12 (6)

TEST M-Alb


800 / 415







PROZONE LIMIT 32000 UPPER

REAGENT R1 250 0 005 #

R2 0 0 005 #

R3 50 0 005 #

R4 0 0 005 #

CALIB. TYPE [Spline] 6 6 0

AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name MALB 2 Assay Code (Mthd) 2 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 415 11 Sample Volume 12 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 0401 10 02 10 October 2009/4

ALKALINE PHOSPHATASE FS DGKC Cat. No 1 0401.........

Notes 1. Please refer to the package insert for Alkaline

Phosphatase FS DGKC 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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST ALP ASSAY CODE 5 – 30 – 50 SAMPLE VOLUME (µl) 4 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 660 – 405 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 13000 – 0 PROZONE LIMIT 0 EXPECTED VALUE 0 – 258 PANIC VALUE 0 - 800 INSTRUMENT FACTOR 1.0




TEST [AP] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [AP] ASSAY/TIME/POINTS [Rate A] [10] [20] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [415]





TEST [AP] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [AP] REPORT NAME [Alkaline Phosphatase] DATA MODE [Aktiv]

TEST NAME [AP] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [AP] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [4] [4] [1] [1] [1] [1]



845 0401 10 02 10 October 2009/4

BM / HITACHI 911


TEST AP # TEST NAME AP UNIT U/L

DATA MODE ON BOARD REPORT NAME Alk. Phos


b 0.0


AGE M F

- -

- -

0 - 258 0 - 258


0 - 800 -


LOT

QUALITATIVE

NO

(1) 0.0 # 4 0 0 # (1)

(2) * # 4 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST AP


700 / 415

ASSAY POINTS 20 - 31 - 0- 0 DILUTION 301 99







REAGENT R1 200 0 084 #

R2 0 0 084 #

R3 50 0 084 #

R4 0 0 084 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name ALP 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 415 11 Sample Volume 4 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 13000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 64 55 Expect. Value (H) 306 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 0441 10 02 10 October 2009/6

ALKALINE PHOSPHATASE FS IFCC 37 °C Cat. No 1 0441.........

Notes 1. Please refer to the package insert for Alkaline

Phosphatase FS IFCC 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.


HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST ALP ASSAY CODE 5 – 30 – 50 SAMPLE VOLUME (µl) 4 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 660 – 405 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 13000 – 0 PROZONE LIMIT 0 EXPECTED VALUE # – # PANIC VALUE 0 - 1400 INSTRUMENT FACTOR 1.0




TEST [AP] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [AP] ASSAY/TIME/POINTS [Rate A] [10] [20] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [415]





TEST [AP] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [AP] REPORT NAME [Alkaline Phosphatase] DATA MODE [Aktiv]

TEST NAME [AP] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]




SAMPLE VOLUME [4] [4] [1] [1] [1] [1]



845 0441 10 02 10 October 2009/6

BM / HITACHI 911


TEST AP # TEST NAME AP UNIT U/L

DATA MODE ON BOARD REPORT NAME Alk. Phos


b 0.0

EXPECTED VALUE CLASS 1 EXPECTED

VALUE

CLASS 2

AGE M F

- -

- -

# - # # - #


0 - 1400 -

STD CO

N

PO

S

S.VO

L.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 4 0 0 # (1)

(2) * # 4 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST AP


700 / 415






ABS. LIMIT 13000] 2:INCREASE


REAGENT R1 200 0 158 #

R2 0 0 158 #

R3 50 0 [158 #

R4 0 0 158 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name ALP 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 415 11 Sample Volume 4 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 13000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 42 55 Expect. Value (H) 141 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 0501 10 02 10 October 2009/5

-AMYLASE CC FS 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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST AMY ASSAY CODE 5 – 40 – 50 SAMPLE VOLUME (µl) 5 R 1 VOLUME (µl) 200 – 20 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 660 – 405 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 10000 – 0 PROZONE LIMIT 0 EXPECTED VALUE 0 – 100 PANIC VALUE 0 - 2000 INSTRUMENT FACTOR 1.0




TEST [AMY] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [AMY] ASSAY/TIME/POINTS [Rate A] [10] [25] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [415]





TEST [AMY] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [AMY] REPORT NAME [Amylase] DATA MODE [Aktiv]

TEST NAME [AMY] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [AMY] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [4] [4] [1] [1] [1] [1]



845 0501 10 02 10 October 2009/5

BM / HITACHI 911


TEST AMY # TEST NAME AMY UNIT U/l

DATA MODE ON BOARD REPORT NAME Amylase


b 0.0


AGE M F

- -

- -

# - # -


0 - 2000 -

STD CO

N

PO

S

S.VO

L.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 4 0 0 # (1)

(2) * # 4 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST AMY


700 / 415








REAGENT R1 200 0 570 #

R2 0 0 570 #

R3 50 0 570 #

R4 0 0 570 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name AMY 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 28 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 415 11 Sample Volume 5 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 10000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 220 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7102 10 02 10 October 2009/6

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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST APOA ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 2 R 1 VOLUME (µl) 250 – 20 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 700 – 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 SD LIMIT 999 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 110 – 190 PANIC VALUE 0.2 - 250 INSTRUMENT FACTOR 1.0



TEST [APOA] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [APOA] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [570]





TEST [APOA] CALIBRATION TYPE [LOGIT/LOG 4P] [ ]

CALIBRATION POINTS

[4] SPAN POINT [4]




Range TEST [APOA] REPORT NAME [Apolipoprotein A1] DATA MODE [Aktiv]

TEST NAME [APOA] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [APOA] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [0] [0]

CONCENTRATION # # # # POSITION # # # #

SAMPLE VOLUME [2] [2] [2] [2] [1] [1]



845 7102 10 02 10 October 2009/6

BM / HITACHI 911


TEST APOA # TEST NAME APOA UNIT mg/dl

DATA MODE ON BOARD REPORT NAME APO A1


b 0.0


AGE M F

- -

- -

110 - 170 120 - 190


0.2 - 250 -


LOT

QUALITATIVE

NO

(1) 0.0 # 2 0 0 # (1)

(2) * # 2 0 0 # (2)

(3) * # 2 0 0 # (3)

(4) * # 2 0 0 # (4)

(5) # 0 0 # (5)

(6) # 0 0 # (6)

TEST APOA

ASSAY CODE 2 point end 10 WAVELGTH (SUB / MAIN)

700 / 570

ASSAY POINTS 15- 31 - 0- 0 DILUTION 301 99







REAGENT R1 250 0 168 #

R2 0 0 168 #

R3 50 0 168 #

R4 0 0 168 #

CALIB. TYPE [LOGIT LOG 4P] 4 4 0

AUTOCALIB.

TIME OUT BLANK 0 SD LIMIT 999





BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name APOA 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 570 11 Sample Volume 2 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Logit-Log 4P 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 2500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 110 55 Expect. Value (H) 190 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7112 10 02 10 May 2009/4

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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST APOB ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 250 – 20 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 700 – 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 SD LIMIT 999 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 75 – 155 PANIC VALUE 0.3 - 250 INSTRUMENT FACTOR 1.0



TEST [APOB] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [APOB] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [340]





TEST [APOB] CALIBRATION TYPE [LOGIT/LOG 4P] [ ]

CALIBRATION POINTS

[4] SPAN POINT [4]




Range TEST [APOB] REPORT NAME [Apolipoprotein B] DATA MODE [Aktiv]

TEST NAME [APOB] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [APOB] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [0] [0]

CONCENTRATION # # # # POSITION # # # #

SAMPLE VOLUME [3] [3] [3] [3] [1] [1]



845 7112 10 02 10 May 2009/4

BM / HITACHI 911


TEST APOB # TEST NAME APOB UNIT mg/dl

DATA MODE ON BOARD REPORT NAME APO B


b 0.0


AGE M F

- -

- -

80 - 155 75 - 150


0.3 - 250 -


LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) * # 3 0 0 # (3)

(4) * # 3 0 0 # (4)

(5) # 0 0 # (5)

(6) # 0 0 # (6)

TEST APOB


700 / 340








REAGENT R1 250 0 151 #

R2 0 0 151 #

R3 50 0 151 #

R4 0 0 151 #

CALIB. TYPE [LOGIT LOG 4P] 4 4 0

AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name APOB 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 340 11 Sample Volume 3 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Logit-Log 4P 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 2500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 45 55 Expect. Value (H) 125 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 2601 10 02 10 March 2010/4

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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST GOT ASSAY CODE 5 – 30 – 50 SAMPLE VOLUME (µl) 15 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 405 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 6000 – 1 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # PANIC VALUE 0 - 700 INSTRUMENT FACTOR 1.0




TEST [ASAT] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [ASAT] ASSAY/TIME/POINTS [Rate A] [10] [20] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [415] [340]





TEST [ASAT] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [ASAT] REPORT NAME [ASAT] DATA MODE [Aktiv]

TEST NAME [ASAT] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [ASAT] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [15] [15] [1] [1] [1] [1]



845 2601 10 02 10 March 2010/4

BM / HITACHI 911


TEST ASAT # TEST NAME ASAT UNIT U/L

DATA MODE ON BOARD REPORT NAME ASAT


b 0.0


AGE M F

- -

- -

# - # # - #


0 - 700 -

STD CON POS S.VOL

.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 15 0 0 # (1)

(2) * # 15 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST ASAT


415 / 340








REAGENT R1 200 0 105 #

R2 0 0 105 #

R3 50 0 105 #

R4 0 0 105 #


AUTOCALIB.






BOTTLE NO

# Data entry by the user * Enter calibration or standard value ** The given factor must be checked by a calibratior ## Enter the next code ATTENTION This kit is for use with the original application. If you wish to use this included DiaSys application please contact your supplier for additional bar code labels.

BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name GOT 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 415 10 Wave Leng. (MAIN) 340 11 Sample Volume 15 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 6000 50 ABS Limit (D/I) Decrease 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 37 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7012 10 02 10 July 2009/5

ANTISTREPTOLYSIN O FS Cat. No 1 7012.........

Notes 1. Please refer to the package insert for Antistreptolysin

O 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.



HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST ASO ASSAY CODE 2 – 32 – 50 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 250 – 20 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 0 – 600 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. * – * SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 - 0 PROZONE LIMIT 32000 - 1 EXPECTED VALUE 0 - 200 PANIC VALUE 7 - 800 INSTRUMENT FACTOR 1.0



TEST [ASO] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [ASO] ASSAY/TIME/POINTS [2 point end] [10] [19] [30] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [600]





TEST [ASO] CALIBRATION TYPE [SPLINE] [ ]

CALIBRATION POINTS

[6] SPAN POINT [3]




Range TEST [ASO] REPORT NAME [Antistreptolysin O] DATA MODE [Aktiv]

TEST NAME [ASO] [] CONTROL INTERVAL UNIT [IU/ml] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [ASO] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [#]


SAMPLE VOLUME [3] [3] [3] [3] [3] [3]



845 7012 10 02 10 July 2009/5

BM / HITACHI 911


TEST ASO # TEST NAME ASO UNIT IU/ml

DATA MODE ON BOARD REPORT NAME ASO


b 0.0


AGE M F

- -

- -

0 - 200 0 -


7 - 800 -


LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) * # 3 0 0 # (3)

(4) * # 3 0 0 # (4)

(5) * # 3 0 0 # (5)

(6) * # 3 0 0 # (6)

TEST ASO


0 / 600








REAGENT R1 250 0 037 #

R2 0 0 037 #

R3 50 0 037 #

R4 0 0 037 #

CALIB. TYPE [SPLINE] 6 3 0

AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name ASO 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 600 11 Sample Volume 3 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Logit-Log 4P 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 2500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 200 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 0950 10 02 10 August 2008/5

BICARBONATE FS 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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CO2 ASSAY CODE 2 – 6 – 42 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 300 – 100 – NO R 2 VOLUME (µl) 0 – 20 – NO WAVELENGTH (nm) 505 – 405 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 SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 1 PROZONE LIMIT -32000 – 0 EXPECTED VALUE 22 – 29 PANIC VALUE 0 – 50 INSTRUMENT FACTOR 1.0



TEST [CO2] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CO2] ASSAY/TIME/POINTS [2 point end] [10] [2] [25] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [505] [415]





TEST [CO2] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [CO2] REPORT NAME [Bicarbonate] DATA MODE [Aktiv]

TEST NAME [CO2] [] CONTROL INTERVAL UNIT [mmol/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]




SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 0950 10 02 10 August 2008/5

BM / HITACHI 911


TEST CO2 # TEST NAME CO2 UNIT mmol/l

DATA MODE ON BOARD REPORT NAME CO2


b 0.0


AGE M F

- -

- -

22 - 29 22 - 29


0 - 50 -


LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CO2


505 / 415






ABS. LIMIT 0 DECREASE


REAGENT R1 300 0 156 #

R2 0 0 156 #

R3 0 0 156 #

R4 0 0 156 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CO2 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 5 6 Assay Point 2 30 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 505 10 Wave Leng. (MAIN) 415 11 Sample Volume 3.0 12 R1 VOLUME 300 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 0 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 200 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Decrease 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 22 55 Expect. Value (H) 29 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 0821 10 02 10 October 2008/4

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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST BIDI ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 20 R 1 VOLUME (µl) 240 – 100 – 0 R 2 VOLUME (µl) 60 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0.0 – 0.3 PANIC VALUE - 10.0 INSTRUMENT FACTOR 1.0



TEST [DBIL] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [DBIL] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [660] [546]





TEST [DBIL] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [DBIL] REPORT NAME [Direct Bilirubin] DATA MODE [Aktiv]

TEST NAME [DBIL] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [DBIL] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [10] [10] [1] [1] [1] [1]



845 0821 10 02 10 October 2008/4

BM / HITACHI 911


TEST DBIL # TEST NAME DBIL UNIT mg/dl

DATA MODE ON BOARD REPORT NAME Bilirubin Direct


b 0.0


AGE M F

- -

- -

0 - 0.2 0 - 0.2


0 - 10.0 -

STD CON POS S.VOL

.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 10 0 0 # (1)

(2) * # 10 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST DBIL

ASSAY CODE 2 point end 10 WAVELGH (SUB / MAIN)

660 / 546








REAGENT R1 240 0 294 #

R2 0 0 294 #

R3 60 0 294 #

R4 0 0 294 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name DBIL 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 546 11 Sample Volume 28 12 R1 VOLUME 280 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0.0 55 Expect. Value (H) 0.25 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 0811 10 02 10 February 2007/3

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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST BILI ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 6 R 1 VOLUME (µl) 240 – 100 – 0 R 2 VOLUME (µl) 60 – 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 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 PANIC VALUE 0.1 – 30.0 INSTRUMENT FACTOR 1.0



TEST [TBIL] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [TBIL] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [660] [546]





TEST [TBIL] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [TBIL] REPORT NAME [Total Bilirubin] DATA MODE [Aktiv]

TEST NAME [TBIL] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [TBIL] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [6] [6] [1] [1] [1] [1]



845 0811 10 02 10 February 2007/3

BM / HITACHI 911


TEST TBIL # TEST NAME TBIL UNIT mg/dl

DATA MODE ON BOARD REPORT NAME Bilirubin Total


b 0.0


AGE M F

- -

- -

0.1 - 1.2 0.1 - 1.2


0 - 30.0 -


LOT

QUALITATIVE

NO

(1) 0.0 # 6 0 0 # (1)

(2) * # 6 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST TBIL


660 / 546








REAGENT R1 240 0 269 #

R2 0 0 269 #

R3 60 0 269 #

R4 0 0 269 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name TBIL 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 546 11 Sample Volume 7 12 R1 VOLUME 280 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0.0 55 Expect. Value (H) 1.0 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1802 10 02 10 August 2008/3

COMPLEMENT C3c FS Cat. No 1 1802.........

Notes 1. Please refer to the package insert for Complement

C3c 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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST C3c ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 4 R 1 VOLUME (µl) 250 – 20 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) – 340 CALIBR. METHOD 3 – 4 – 6 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. * – * STD.3 CONC.-POS. * – * STD.4 CONC.-POS. * – * STD.5 CONC.-POS. * – * STD.6 CONC.-POS. * – * SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 90 – 180 PANIC VALUE 1 – 500 INSTRUMENT FACTOR 1.0



TEST [C3] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [C3] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [340]





TEST [C3] CALIBRATION TYPE [Spline] [ ]

CALIBRATION POINTS

[6] SPAN POINT [4]




Range TEST [C3] REPORT NAME [Complement C3c] DATA MODE [Aktiv]

TEST NAME [C3] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [C3] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [4] [4] [4] [4] [4] [4]



845 1802 10 02 10 August 2008/3

BM / HITACHI 911


TEST C3C # TEST NAME C3C UNIT mg/dl

DATA MODE ON BOARD REPORT NAME C3C


b 0.0


AGE M F

- -

- -

90 - 180 # - #


1 - 500 -


LOT

QUALITATIVE

NO

(1) 0.0 # 4 0 0 # (1)

(2) * # 4 0 0 # (2)

(3) * # 4 0 0 # (3)

(4) * # 4 0 0 # (4)

(5) * # 4 0 0 # (5)

(6) * # 4 0 0 # (6)

TEST C3C


0 / 340








REAGENT R1 250 0 036 #

R2 0 0 036 #

R3 50 0 036 #

R4 0 0 036 #

CALIB. TYPE SPLINE 6 6 0

AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name C3 2 Assay Code (Mthd) 2 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) - 10 Wave Leng. (MAIN) 340 11 Sample Volume 4 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 1000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1812 10 02 10 August 2008/3

COMPLEMENT C4 FS Cat. No 1 1812.........

Notes 1. Please refer to the package insert for Complement

C4 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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST C4 ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 7 R 1 VOLUME (µl) 250 – 20 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) – 340 CALIBR. METHOD 3 – 4 – 6 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. * – * STD.3 CONC.-POS. * – * STD.4 CONC.-POS. * – * STD.5 CONC.-POS. * – * STD.6 CONC.-POS. * – * SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 10 – 40 PANIC VALUE 0.6 - 90 INSTRUMENT FACTOR 1.0



TEST [C4] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [C4] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [340]





TEST [C4] CALIBRATION TYPE [Spline] [ ]

CALIBRATION POINTS

[6] SPAN POINT [4]




Range TEST [C4] REPORT NAME [Complement C4] DATA MODE [Aktiv]

TEST NAME [C4] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [C3] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [7] [7] [7] [7] [7] [7]



845 1812 10 02 10 August 2008/3

BM / HITACHI 911


TEST C4 # TEST NAME C4 UNIT mg/dl

DATA MODE ON BOARD REPORT NAME C4


b 0.0


AGE M F

- -

- -

10 - 40 # - #


0.6 - 90 -


LOT

QUALITATIVE

NO

(1) 0.0 # 7 0 0 # (1)

(2) * # 7 0 0 # (2)

(3) * # 7 0 0 # (3)

(4) * # 7 0 0 # (4)

(5) * # 7 0 0 # (5)

(6) * # 7 0 0 # (6)

TEST C4


0 / 340








REAGENT R1 250 0 032 #

R2 0 0 032 #

R3 50 0 032 #

R4 0 0 032 #

CALIB. TYPE SPLINE] 6 6 0

AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name C4 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) - 10 Wave Leng. (MAIN) 340 11 Sample Volume 7 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 1000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1130 10 02 10 September 2009/3

CALCIUM AS FS Cat. No 1 1130.........

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


2. The stability of the reagent on board the analyser is 6 weeks provided that contamination and evaporation are avoided.




HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CALC ASSAY CODE 1 – 50 – 0 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 250 – 100 – NO R 2 VOLUME (µl) 0 – 20 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 100 – 1 EXPECTED VALUE 8.6 – 10.3 PANIC VALUE 0.04 – 25.0 INSTRUMENT FACTOR 1.0



TEST [CA] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CA] ASSAY/TIME/POINTS [1 point] [10] [31] [0] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [660]





TEST [CA] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [CA] REPORT NAME [Calcium] DATA MODE [Aktiv]

TEST NAME [CA] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [CA] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 1130 10 02 10 September 2009/3

BM / HITACHI 911


TEST CA # TEST NAME CA UNIT mg/dl

DATA MODE ON BOARD REPORT NAME Calcium


b 0.0


AGE M F

- -

- -

8.6 - 10.3 8.6 - 10.3


0 - 25.0 -


LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CA


700 / 660








REAGENT R1 250 0 381 #

R2 0 0 381 #

R3 0 0 381 #

R4 0 0 381 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CAL 2 Assay Code (Mthd) 1 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 35 6 Assay Point 2 0 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 660 11 Sample Volume 3 12 R1 VOLUME 300 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 0 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 600 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 8.6 55 Expect. Value (H) 10.3 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1121 10 02 10 September 2006/3

CALCIUM CPC FS Cat. No 1 1121.........

Notes 1. Please refer to the package insert for Calcium CPC






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CALC ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 5 R 1 VOLUME (µl) 240 – 100 – 0 R 2 VOLUME (µl) 60 – 20 – 0 WAVELENGTH (nm) 660 – 570 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 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 PANIC VALUE 0.2 – 20.0 INSTRUMENT FACTOR 1.0



TEST [CA] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CA] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [660] [570]






CALIBRATION POINTS

[2] SPAN POINT [2]









SAMPLE VOLUME [5] [5] [1] [1] [1] [1]



845 1121 10 02 10 September 2006/3

BM / HITACHI 911





b 0.0


AGE M F

- -

- -

8.6 - 10.3 8.6 - 10.3


0.2 - 20.0 -


LOT

QUALITATIVE

NO

(1) 0.0 # 5 0 0 # (1)

(2) * # 5 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CA


660 / 570








REAGENT R1 240 0 380 #

R2 0 0 380 #

R3 60 0 380 #

R4 0 0 380 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CA 2 Assay Code (Mthd) 2 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 570 11 Sample Volume 5 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 8.6 55 Expect. Value (H) 10.4 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1181 10 02 10 March 2010/5

CALCIUM P FS Cat. No 1 1181.........

Notes 1. Please refer to the package insert for Calcium P 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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CALC ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 240 – 100 – 0 R 2 VOLUME (µl) 60 – 20 – 0 WAVELENGTH (nm) 0 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 8.6 – 10.3 PANIC VALUE 0.1 – 25.0 INSTRUMENT FACTOR 1.0



TEST [CA] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CA] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [800] [660]






CALIBRATION POINTS

[2] SPAN POINT [2]









SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 1181 10 02 10 March 2010/5

BM / HITACHI 911





b 0.0


AGE M F

- -

- -

8.6 - 10.3 8.6 - 10.3


0.1 - 25.0 -


LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CA


800 / 660






ABS. LIMIT 0 1:DECREASE


REAGENT R1 240 0 264 #

R2 0 0 264 #

R3 60 0 264 #

R4 0 0 264 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CA 2 Assay Code (Mthd) 2 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 0 10 Wave Leng. (MAIN) 660 11 Sample Volume 3 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Decrease 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 8.6 55 Expect. Value (H) 10.4 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1401 10 02 10 October 2008/5

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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CHE ASSAY CODE 5 – 30 – 50 SAMPLE VOLUME (µl) 4 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 0 – 405 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 1 PROZONE LIMIT 0 EXPECTED VALUE 3930 – 11500 PANIC VALUE 0 - 20000 INSTRUMENT FACTOR 1.0




TEST [CHE] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CHE] ASSAY/TIME/POINTS [Rate A] [10] [21] [30] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [415]





TEST [CHE] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [CHE] REPORT NAME [Cholinesterase] DATA MODE [Aktiv]

TEST NAME [CHE] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]




SAMPLE VOLUME [4] [4] [1] [1] [1] [1]



845 1401 10 02 10 October 2008/5

BM / HITACHI 911


TEST CHE # TEST NAME CHE UNIT U/l

DATA MODE ON BOARD REPORT NAME CHE


b 0.0


AGE M F

- -

- -

# - # # - #


0 - 20000 -


LOT

QUALITATIVE

NO

(1) 0 # 4 0 0 # (1)

(2) * # 4 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CHE


/ 415






ABS. LIMIT 0 1:DECREASE


REAGENT R1 200 0 434 #

R2 0 0 434 #

R3 50 0 434 #

R4 0 0 434 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CHE 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 22 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 0 10 Wave Leng. (MAIN) 415 11 Sample Volume 4 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Decrease 51 Prz. Limit 32000 52 Prz. Limit (U/D) Higher 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1200 10 02 10 September 2009/3

CHLORIDE FS Cat. No 1 1200.........

Notes 1. Please refer to the package insert for Chloride FS






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CL ASSAY CODE 1 – 50 – 0 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 250 – 20 – NO R 2 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 EXPECTED VALUE 95 – 105 PANIC VALUE 1 - 130 INSTRUMENT FACTOR 1.0



TEST [CL] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CL] ASSAY/TIME/POINTS [1 point] [10] [31] [0] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [480]





TEST [CL] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [CL] REPORT NAME [Chloride] DATA MODE [Aktiv]

TEST NAME [CL] [] CONTROL INTERVAL UNIT [mmol/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [CL] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 1200 10 02 10 September 2009/3

BM / HITACHI 911


TEST CL # TEST NAME CL UNIT mmol/l

DATA MODE ON BOARD REPORT NAME Chloride


b 0.0


AGE M F

- -

- -

95 - 105 95 - 105


1 - 130 -


LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CL


700 / 480








REAGENT R1 250 0 379 #

R2 0 0 379 #

R3 0 0 379 #

R4 0 0 379 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CL 2 Assay Code (Mthd) 1 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 35 6 Assay Point 2 0 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 600 10 Wave Leng. (MAIN) 480 11 Sample Volume 3 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 0 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 98 55 Expect. Value (H) 107 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1300 10 02 10 September 2005/2

CHOLESTEROL FS Cat. No 1 1300.........

Notes 1. Please refer to the package insert for Cholesterol







HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CHOL ASSAY CODE 1 – 50 – 0 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 250 – 100 – NO R 2 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 200 PANIC VALUE 3 - 750 INSTRUMENT FACTOR 1.0



TEST [CHOL] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CHOL] ASSAY/TIME/POINTS [1 point] [10] [31] [0] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [505]





TEST [CHOL] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [CHOL] REPORT NAME [Cholesterol] DATA MODE [Aktiv]

TEST NAME [CHOL] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [CHOL] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 1300 10 02 10 September 2005/2

BM / HITACHI 911


TEST CHOL # TEST NAME CHOL UNIT mg/dl

DATA MODE ON BOARD REPORT NAME CHOLESTEROL


b 0.0


AGE M F

- -

- -

0 - 200 0 - 200


3 - 750 -

STD CON POS S.VOL

.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CHOL


700 / 505








REAGENT R1 250 0 263 #

R2 0 0 263 #

R3 0 0 263 #

R4 0 0 263 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CHOL 2 Assay Code (Mthd) 1 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 35 6 Assay Point 2 0 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 505 11 Sample Volume 3.0 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 0 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 2000 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 220 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1641 10 02 10 May 2010/2

CK-MB FS Cat. No 1 1641.........

Notes 1. Please refer to the package insert for CK-MB FS for



at least 6 weeks provided that contamination and evaporation are avoided.



HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CKMB ASSAY CODE 5 – 40 – 50 SAMPLE VOLUME (µl) 10 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 405 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT (INC/DEC) 9000 – 0 PROZONE LIMIT 0 EXPECTED VALUE 0 – 24 PANIC VALUE 0 - 2000 INSTRUMENT FACTOR 1.0




TEST [CK-MB] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CK-MB] ASSAY/TIME/POINTS [Rate A] [10] [25] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [415] [340]





TEST [CK-MB] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [CK-MB] REPORT NAME [CK-MB] DATA MODE [Aktiv]

TEST NAME [CK-MB] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [CK-MB] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [10] [10] [1] [1] [1] [1]



845 1641 10 02 10 May 2010/2

BM / HITACHI 911


TEST CKMB # TEST NAME CKMB UNIT U/L

DATA MODE ON BOARD REPORT NAME CK-MB


b 0.0


AGE M F

- -

- -

# - # # - #


0 - 2000 -

STD CON POS S.VOL

.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 10 0 0 # (1)

(2) * # 10 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CKMB

ASSAY CODE RATE A 10 WAVELGTH (SUB / MAIN)

415 / 340







PROZONE LIMIT 0 HIGHER

REAGENT R1 200 0 060 #

R2 0 0 060 #

R3 50 0 060 #

R4 0 0 060 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CKMB 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 28 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 415 10 Wave Leng. (MAIN) 340 11 Sample Volume 10 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 9000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 24 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1651 10 02 10 October 2009/6

CK-MB FS Cat. No 1 1651.........

Notes 1. Please refer to the package insert for CK-MB FS for






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CKMB ASSAY CODE 5 – 40 – 50 SAMPLE VOLUME (µl) 10 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 405 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 9000 – 0 PROZONE LIMIT 0 EXPECTED VALUE 0 – 24 PANIC VALUE 0 - 2000 INSTRUMENT FACTOR 1.0




TEST [CK-MB] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CK-MB] ASSAY/TIME/POINTS [Rate A] [10] [25] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [415] [340]





TEST [CK-MB] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [CK-MB] REPORT NAME [CK-MB] DATA MODE [Aktiv]

TEST NAME [CK-MB] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [CK-MB] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [10] [10] [1] [1] [1] [1]



845 1651 10 02 10 October 2009/6

BM / HITACHI 911


TEST CKMB # TEST NAME CKMB UNIT U/L

DATA MODE ON BOARD REPORT NAME CK-MB


b 0.0


AGE M F

- -

- -

# - # # - #


0 - 2000 -

STD CON POS S.VOL

.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 10 0 0 # (1)

(2) * # 10 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CKMB

ASSAY CODE RATE A 10 WAVELGTH (SUB / MAIN)

415 / 340







PROZONE LIMIT 0 HIGHER

REAGENT R1 200 0 060 #

R2 0 0 060 #

R3 50 0 060 #

R4 0 0 060 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CKMB 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 28 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 415 10 Wave Leng. (MAIN) 340 11 Sample Volume 10 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 9000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 24 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1601 10 02 10 October 2009/6

CK-NAC FS Cat. No 1 1601.........

Notes 1. Please refer to the package insert for CK-NAC FS






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CK ASSAY CODE 5 – 35 – 50 SAMPLE VOLUME (µl) 7 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 405 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 9000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # PANIC VALUE 0 - 1100 INSTRUMENT FACTOR 1.0




TEST [CK] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CK] ASSAY/TIME/POINTS [Rate A] [10] [22] [30] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [415] [340]





TEST [CK] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [CK] REPORT NAME [CK] DATA MODE [Aktiv]

TEST NAME [CK] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [CK] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [7] [7] [1] [1] [1] [1]



845 1601 10 02 10 October 2009/6

BM / HITACHI 911


TEST CK # TEST NAME CK UNIT U/L

DATA MODE ON BOARD REPORT NAME CK-NAC


b 0.0


AGE M F

- -

- -

# - # # - #


0 - 1100 -

STD CON POS S.VOL

.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 7 0 0 # (1)

(2) * # 7 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CK


415 / 340








REAGENT R1 200 0 057 #

R2 0 0 057 #

R3 50 0 057 #

R4 0 0 057 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CK 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 24 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 415 10 Wave Leng. (MAIN) 340 11 Sample Volume 7 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 9000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 24 55 Expect. Value (H) 190 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1711 10 02 10 March 2008/4

CREATININE FS Cat. No 1 1711.........

Notes 1. Please refer to the package insert for Creatinine FS






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CREA ASSAY CODE 5 – 30 – 37 SAMPLE VOLUME (µl) 15 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 4500 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0.6 – 1.3 PANIC VALUE 0.2 – 15.0 INSTRUMENT FACTOR 1.0



TEST [CREA] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CREA] ASSAY/TIME/POINTS [2 point rate] [10] [19] [24] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [570] [505]





TEST [CREA] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [CREA] REPORT NAME [Creatinine] DATA MODE [Aktiv]

TEST NAME [CREA] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [CREA] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [15] [15] [1] [1] [1] [1]



845 1711 10 02 10 March 2008/4

BM / HITACHI 911


TEST CREA # TEST NAME CREA UNIT mg/dl

DATA MODE ON BOARD REPORT NAME CREATININE


b 0.0


AGE M F

- -

- -

0.9 - 1.3 0.6 - 1.1


0.2 - 15.0 -


LOT

QUALITATIVE

NO

(1) 0.0 # 15 0 0 # (1)

(2) * # 15 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CREA

ASSAY CODE 2 POINT

RATE

10 WAVELGTH (SUB / MAIN)

570 / 505








REAGENT R1 200 0 400 #

R2 0 0 400 #

R3 50 0 400 #

R4 0 0 400 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CREA 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 26 7 Assay Point 3 10 8 Assay Point 4 15 9 Wave Leng. (SUB) 570 10 Wave Leng. (MAIN) 505 11 Sample Volume 15 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 4500 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0.5 55 Expect. Value (H) 1.1 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1711 10 02 10 March 2008/4

CREATININE FS Compensated Method To use the Creatinine FS Compensated Methodon the Hitachi 912, 911 and 902 the Instrument factor ’b’ must be changed as follows; When the units are mg/dL

Instrument Factor (Y=aX+b) b= - 0.3 When the units are µmol/L

Instrument Factor (Y=aX+b) b= - 27 To use the Creatinine Compensated Method on the Hitachi 717 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

HITACHI 717

Chemistry settings PROGRAM 2: CHEMISTRY PARAMETERS TEST CREA ASSAY CODE 5 – 30 – 37 SAMPLE VOLUME (µl) 15 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 4500 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0.6 – 1.3 PANIC VALUE 0.2 – 15.0 INSTRUMENT FACTOR 1.0



TEST [CREA] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CREA] ASSAY/TIME/POINTS [2 point rate] [10] [19] [24] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [570] [505]





TEST [CREA] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [CREA] REPORT NAME [Creatinine] DATA MODE [Aktiv]

TEST NAME [CREA] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [-0.30]


TEST [CREA] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [15] [15] [1] [1] [1] [1]



845 1711 10 02 10 March 2008/4

BM / HITACHI 911





b -0.3


AGE M F

- -

- -

0.9 - 1.3 0.6 - 1.1


0.2 - 15.0 -


LOT

QUALITATIVE

NO

(1) 0.0 # 15 0 0 # (1)

(2) * # 15 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CREA

ASSAY CODE 2 POINT

RATE

10 WAVELGTH (SUB / MAIN)

570 / 505








REAGENT R1 200 0 400 #

R2 0 0 400 #

R3 50 0 400 #

R4 0 0 400 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CREA 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 26 7 Assay Point 3 10 8 Assay Point 4 15 9 Wave Leng. (SUB) 570 10 Wave Leng. (MAIN) 505 11 Sample Volume 15 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 4500 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0.5 55 Expect. Value (H) 1.1 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) -0.3 58 Key Setting #


845 1759 10 02 10 September 2005/2

CREATININE PAP FS Cat. No 1 1759.........

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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CREA ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 6 R 1 VOLUME (µl) 250 – 100 – NO R 2 VOLUME (µl) 125 – 100 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0.6 – 1.3 PANIC VALUE # – # INSTRUMENT FACTOR 1.0



TEST [Crea] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [Crea] ASSAY/TIME/POINTS [2 Point End] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [546]



CLASS 1 CLASS 2 DECR./INCR. R4 [0] [0] [00063] [#] ABSORBANCE LIMIZ [0] [0] [increase] TWINTEST [ ]


TEST [Crea] KALIBRATIONS TYP [Linear] [ ]

CALIBRATION POINTS [2] SPAN POINT [2] WEIGHT [0]

AUTOMATIC CALIBRATION AUTO TIME OUT AUTO CHANGE

BLANK [0] St LOT [ ] SD LIMIT [0.1] SPAN [0] St BOTTLE [ ] DUPLICATE LIMIT [10] % [200] ABS

2-POINT [0] St SENSITIVITY LIMIT [-99999] - [99999] FULL [0] St S1 ABS. LIMIT [-32000] - [32000]

Range TEST [Crea] REPORT NAME [Creatinin] DATA MODE [Aktiv]

TEST NAME [Crea] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [Crea] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [6] [6] [1] [1] [1] [1]



845 1759 10 02 10 September 2005/2

BM / HITACHI 911





b 0.0


AGE M F

- -

- -

0.9 - 1.3 0.6 - 1.1


# - # -


LOT

QUALITATIVE

NO

(1) 0.0 # 6 0 0 # (1)

(2) * # 6 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST CREA

ASSAY CODE 2 POINT END 10 WAVELGTH (SUB / MAIN)

700 / 546








REAGENT R1 250 0 063 #

R2 0 0 063 #

R3 125 0 063 #

R4 0 0 063 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CRE 2 Assay Code (Mthd) 2 point end 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 546 11 Sample Volume 6 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 17 R2 Bottle Size Small 18 R3 VOLUME 125 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 1000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0.9 55 Expect. Value (H) 1.3 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7045 10 42 10 August 2008/5

CRP U-hs High sensitive (hs) application

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

Notes 1. Please refer to the package insert for CRP U-hs for






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CRPS ASSAY CODE 2 – 31 – 50 SAMPLE VOLUME (µl) 15 R 1 VOLUME (µl) 150 – 20 – NO R 2 VOLUME (µl) 150 – 20 – NO WAVELENGTH (nm) 800 – 505 CALIBR. METHOD 3 – 1 – 6 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. * - * STD.3 CONC.-POS. * – * STD.4 CONC.-POS. * – * STD.5 CONC.-POS. * – * STD.6 CONC.-POS. * – * SD LIMIT 999 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 0 – 5 PANIC VALUE 0.05 – 20 INSTRUMENT FACTOR 1.0



TEST [CRP] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [CRP] ASSAY/TIME/POINTS [2 point end] [10] [19] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [800] [505]





TEST [CRP] CALIBRATION TYPE [SPLINE] [ ]

CALIBRATION POINTS

[6] SPAN POINT [6]




Range TEST [CRP] REPORT NAME [CRP] DATA MODE [Aktiv]

TEST NAME [CRP] [] CONTROL INTERVAL UNIT [mg/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [CRP] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [#]


SAMPLE VOLUME [15] [15] [15] [15] [15] [15]



845 7045 10 42 10 August 2008/5

BM / HITACHI 911


TEST CRP # TEST NAME CRP UNIT mg/l

DATA MODE ON BOARD REPORT NAME CRP US


b 0.0


AGE M F

- -

- -

0.0 - 5 0.0 - 5


0. 05 - 20 -


LOT

QUALITATIVE

NO

(1) 0.00 # 15 0 0 # (1)

(2) # # 15 0 0 # (2)

(3) # # 15 0 0 # (3)

(4) # # 15 0 0 # (4)

(5) # # 15 0 0 # (5)

(6) # # 15 0 0 (6)

TEST CRP


800 / 505








REAGENT R1 150 0 218 #

R2 0 0 218 #

R3 150 0 218 #

R4 0 0 218 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CRP 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 32 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 800 10 Wave Leng. (MAIN) 505 11 Sample Volume 17 12 R1 VOLUME 170 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 170 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 0.5 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7045 10 32 10 August 2008/5

CRP U-hs Universal (U) application Cat. No 1 7045.........

Notes 1. Please refer to the package insert for CRP U-hs for






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CRPS ASSAY CODE 2 – 31 – 50 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 150 – 20 – NO R 2 VOLUME (µl) 150 – 20 – NO WAVELENGTH (nm) 800 – 505 CALIBR. METHOD 3 – 1 – 6 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. * - * STD.3 CONC.-POS. * – * STD.4 CONC.-POS. * – * STD.5 CONC.-POS. * – * STD.6 CONC.-POS. * – * SD LIMIT 999 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 0 – 5 PANIC VALUE 0.3 – 350 INSTRUMENT FACTOR 1.0








TEST [CRP] CALIBRATION TYPE [SPLINE] [ ]

CALIBRATION POINTS

[6] SPAN POINT [6]





TEST NAME [CRP] [] CONTROL INTERVAL UNIT [mg/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]




SAMPLE VOLUME [3] [3] [3] [3] [3] [3]



845 7045 10 32 10 August 2008/5

BM / HITACHI 911


TEST CRP # TEST NAME CRP UNIT mg/l

DATA MODE ON BOARD REPORT NAME CRP DY


b 0.0


AGE M F

- -

- -

0.0 - 5 0.0 - 5


0. 3 - 350 -

STD CO

N

PO

S

S.VO

L.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.00 # 3 0 0 # (1)

(2) # # 3 0 0 # (2)

(3) # # 3 0 0 # (3)

(4) # # 3 0 0 # (4)

(5) # # 3 0 0 # (5)

(6) # # 3 0 0 (6)

TEST CRP


800 / 505








REAGENT R1 150 0 218 #

R2 0 0 218 #

R3 150 0 218 #

R4 0 0 218 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CRP 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 32 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 800 10 Wave Leng. (MAIN) 505 11 Sample Volume 3 12 R1 VOLUME 170 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 170 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 0.5 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7002 10 02 10 August 2008/4

CRP FS Cat. No 1 7002.........

Notes 1. Please refer to the package insert for CRP FS for






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST CRP ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 15 R 1 VOLUME (µl) 250 – 20 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 700 – 340 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. * – * SD LIMIT 999 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 0 – 0.5 PANIC VALUE 0.2 – 25.0 INSTRUMENT FACTOR 1.0








TEST [CRP] CALIBRATION TYPE [LOGIT/LOG 4P] [ ]

CALIBRATION POINTS

[6] SPAN POINT [6]





TEST NAME [CRP] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]




SAMPLE VOLUME [15] [15] [15] [15] [15] [15]


#) data entry by the user *) enter calibration or standard value and position n

845 7002 10 02 10 August 2008/4

BM / HITACHI 911


TEST CRP # TEST NAME CRP UNIT mg/dl

DATA MODE ON BOARD REPORT NAME CRP


b 0.0


AGE M F

- -

- -

0.0 - 0.5 0.0 - 0.5


0.2 - 25.0 -

STD CON POS S.VOL

.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.00 # 15 0 0 # (1)

(2) * # 15 0 0 # (2)

(3) * # 15 0 0 # (3)

(4) * # 15 0 0 # (4)

(5) * # 15 0 0 # (5)

(6) * # 15 0 0 # (6)

TEST CRP


700 / 340








REAGENT R1 250 0 704 #

R2 0 0 704 #

R3 50 0 704 #

R4 0 0 704 #

CALIB. TYPE [LOGIT LOG 4P] 6 6 0 0

AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name CRP 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 340 11 Sample Volume 15 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Spline 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 0.8 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7059 10 02 10 August 2008/3

FERRITIN FS Cat. No 1 7059.........

Notes 1. Please refer to the package insert for Ferritin FS for






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST FERR ASSAY CODE 2 – 27 – 42 SAMPLE VOLUME (µl) 8 R 1 VOLUME (µl) 160 – 20 – NO R 2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 800– 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 SD LIMIT 999 DUPLICATE LIMIT 32000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 32000 – 0 PROZONE LIMIT -32000 – 1 EXPECTED VALUE 30 – 300 PANIC VALUE 5 - 1000 INSTRUMENT FACTOR 1.0



TEST [FER] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [FER] ASSAY/TIME/POINTS [2 point end] [10] [18] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [800] [570]




PROZONE LIMIT [-32000] [0] [lower] Calibration

TEST [FER] CALIBRATION TYPE [Spline] [ ]

CALIBRATION POINTS

[5] SPAN POINT [5]




Range TEST [FER] REPORT NAME [Ferritin] DATA MODE [Aktiv]

TEST NAME [FER] [] CONTROL INTERVAL UNIT [µg/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [FER] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [0]

CONCENTRATION # # # # # POSITION # # # # #

SAMPLE VOLUME [8] [8] [8] [8] [8] [1]



845 7059 10 02 10 August 2008/3

BM / HITACHI 911


TEST FER # TEST NAME FER UNIT µg/l

DATA MODE ON BOARD REPORT NAME FERRITIN


b 0.0


AGE M F

- -

- -

30 - 300 10 - 160


5 - 1000 -


LOT

QUALITATIVE

NO

(1) 0 # 8 0 0 # (1)

(2) * # 8 0 0 # (2)

(3) * # 8 0 0 # (3)

(4) * # 8 0 0 # (4)

(5) * # 8 0 0 # (5)

(6) (6)

TEST FER


800 / 570







PROZONE LIMIT -32000 LOWER

REAGENT R1 160 0 164 #

R2 0 0 164 #

R3 80 0 164 #

R4 0 0 164 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name Ferr 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 20 6 Assay Point 2 32 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 800 10 Wave Leng. (MAIN) 570 11 Sample Volume 10 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 100 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 34 Calib. Pos. 6 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit -32000 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 10 55 Expect. Value (H) 300 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 2801 10 02 10 October 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.



HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST GGT ASSAY CODE 5 – 30 – 50 SAMPLE VOLUME (µl) 8 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 660 – 405 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 8000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # PANIC VALUE 0 - 1200 INSTRUMENT FACTOR 1.0




TEST [GGT] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [GGT] ASSAY/TIME/POINTS [Rate A] [10] [20] [30] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [415]





TEST [GGT] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [GGT] REPORT NAME [Gamma GT] DATA MODE [Aktiv]

TEST NAME [GGT] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [GGT] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [8] [8] [1] [1] [1] [1]



845 2801 10 02 10 October 2009/3

BM / HITACHI 911


TEST GGT # TEST NAME GGT UNIT U/l

DATA MODE ON BOARD REPORT NAME Gamma-GT


b 0.0


AGE M F

- -

- -

# - # # - #


0 - 1200 -


LOT

QUALITATIVE

NO

(1) 0.0 # 8 0 0 # (1)

(2) * # 8 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST GGT


700 / 415

ASSAY POINTS 20- 30 - 0 - 0 DILUTION 301 99







REAGENT R1 200 0 479 #

R2 0 0 479 #

R3 50 0 479 #

R4 0 0 479 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name GGT 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 415 11 Sample Volume 8 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 8000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 7 55 Expect. Value (H) 50 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 2411 10 02 10 March 2009/1

GLDH FS DGKC Cat. No 1 2411.........

Notes 1. Please refer to the package insert for GLDH FS

DGKC 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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST GLDH ASSAY CODE 5 – 28 – 44 SAMPLE VOLUME (µl) 20 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 405 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 8000 – 1 PROZONE LIMIT 0 EXPECTED VALUE 0– 7 PANIC VALUE 0 - 120 INSTRUMENT FACTOR 1.0




TEST [GLDH] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [GLDH] ASSAY/TIME/POINTS [Rate A] [10] [18] [27] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [415] [340]

SAMPLE VOLUME CLASS 1 CLASS 2 REAGENT NORMAL [30] [0] [0] [1] [0] [0] R1 [200] [0] [#] [#]

DECREASE [5] [0] [0] [1] [0] [0] R2 [0] [0] [#] [#] INCREASE [40] [0] [0] [1] [0] [0] R3 [50] [0] [#] [#]

CLASS 1 CLASS 2 DECR./INCR. R4 [0] [0] [#] [#] ABSORBANCE LIMIT [8000] [0] [decrease] TWINTEST [ ]


TEST [GLDH] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [GLDH] REPORT NAME [GLDH] DATA MODE [Aktiv]

TEST NAME [GLDH] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [GLDH] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [30] [30] [1] [1] [1] [1]



845 2411 10 02 10 March 2009/1

BM / HITACHI 911


TEST GLDH # TEST NAME GLDH UNIT U/L

DATA MODE ON BOARD REPORT NAME GLDH


b 0.0


AGE M F

- -

- -

0 - 7 0 - 5


0 - 120 -

STD CON POS S.VOL. PRE. DIL. VOL CODE LOT QUALITATIVE NO

(1) 0.0 # 30 0 0 # (1)

(2) * # 30 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST GLDH


415 / 340








REAGENT R1 200 0 # #

R2 0 0 # #

R3 50 0 # #

R4 0 0 # #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name GLDH 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 31 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 415 10 Wave Leng. (MAIN) 340 11 Sample Volume 30 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 8000 50 ABS Limit (D/I) Decrease 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 7 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 2500 10 02 10 February 2008/4

GLUCOSE GOD FS Cat. No 1 2500.........

Notes 1. Please refer to the package insert for Glucose GOD






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST GLUC ASSAY CODE 1 – 50 – 0 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 250 – 100 – NO R 2 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 SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 EXPECTED VALUE 70 – 115 PANIC VALUE 1 - 400 INSTRUMENT FACTOR 1.0



TEST [GLUC] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [GLUC] ASSAY/TIME/POINTS [1 point] [10] [31] [0] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [505]





TEST [GLUC] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [GLUC] REPORT NAME [Glucose] DATA MODE [Aktiv]

TEST NAME [GLUC] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [GLUC] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 2500 10 02 10 February 2008/4

BM / HITACHI 911


TEST GLUC # TEST NAME GLUC UNIT mg/dl

DATA MODE ON BOARD REPORT NAME GLucose


b 0.0


AGE M F

- -

- -

70 - 115 70 - 115


1 - 400 -


LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST GLUC


700 / 505








REAGENT R1 250 0 249 #

R2 0 0 249 #

R3 0 0 249 #

R4 0 0 249 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name GLU 2 Assay Code (Mthd) 1 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 35 6 Assay Point 2 0 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 505 11 Sample Volume 2.5 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 0 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 75 55 Expect. Value (H) 115 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 2511 10 02 10 March 2009/4

GLUCOSE HEXOKINASE FS Cat. No 1 2511.........

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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST GLUC ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 240 – 100 – NO R 2 VOLUME (µl) 60 – 20 – NO WAVELENGTH (nm) 405 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 - 0 EXPECTED VALUE 70 – 115 PANIC VALUE 2 - 900 INSTRUMENT FACTOR 1.0



TEST [GLUC] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [GLUC] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [376] [340]





TEST [GLUC] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [GLUC] REPORT NAME [Glucose] DATA MODE [Aktiv]

TEST NAME [GLUC] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [GLUC] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 2511 10 02 10 March 2009/4

BM / HITACHI 911


TEST GLUC # TEST NAME GLUC UNIT mg/dl

DATA MODE ON BOARD REPORT NAME GLucose


b 0.0


AGE M F

- -

- -

70 - 115 70 - 115


2 - 500 -

STD CON POS S.VOL

.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST GLUC


376 / 340








REAGENT R1 240 0 248 #

R2 0 0 248 #

R3 60 0 248 #

R4 0 0 248 #


AUTOCALIB.






BOTTLE NO

# Data entry by the user * Enter calibration or standard value ## Enter the next code ATTENTION This kit is for use with the original application. If you wish to use this included DiaSys application please contact your supplier for additional bar code labels.

BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name GLU 2 Assay Code (Mthd) 2 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 415 10 Wave Leng. (MAIN) 340 11 Sample Volume 3 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 75 55 Expect. Value (H) 115 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 3329 10 02 10 January 2010/7

HbA1c FS Cat. No 1 3329.....

Notes 1. Please refer to the package insert for oneHbA1c for


2. The stability of the reagent on board the analyser is 8

weeks provided that contamination and evaporation are avoided.



Attention: Immediately after HbA1c measurement cleaning of cuvettes with NaOH-D solution is necessary. Please, refer to the information of the analyzer manufacturer. **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.

HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST HbA1c ASSAY CODE 1 – 50 – 0 SAMPLE VOLUME (µl) 4 R 1 VOLUME (µl) 180 – 20 – 0 R 2 VOLUME (µl) 90 – 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 SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 32000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # PANIC VALUE # – # INSTRUMENT FACTOR 1.0


**) Spline function


TEST [HbA1c] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [HbA1c] ASSAY/TIME/POINTS [1 point ] [10] [20] [0] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [660]





TEST [HbA1c] CALIBRATION TYPE [Spline] [ ]

CALIBRATION POINTS

[5] SPAN POINT [5]




Range TEST [HbA1c] REPORT NAME [HbA1c] DATA MODE [Aktiv]

TEST NAME [HbA1c] [] CONTROL INTERVAL UNIT [ # ] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]

SAMPLE TYPE [#] Reference ranges and technical limits: entry by user / see package insert Standards

TEST [DBIL] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [0]

CONCENTRATION # # # # # POSITION # # # # #

SAMPLE VOLUME [4] [4] [4] [4] [4] [0]



845 3329 10 02 10 January 2010/7

BM / HITACHI 911


TEST HbA1c # TEST NAME HbA1c UNIT #

DATA MODE ON BOARD REPORT NAME Hemoglobin A1c


b 0.0


AGE M F

- -

- -

# - # # - #


# - # -


LOT

QUALITATIVE

NO

(1) 0.0 # 4 0 0 # (1)

(2) * # 4 0 0 # (2)

(3) * # 4 0 0 # (3)

(4) * # 4 0 0 # (4)

(5) * # 4 0 0 # (5)

(6) (6)

TEST HbA1c

ASSAY CODE 1 Point 10 WAVELGH (SUB / MAIN)

0 / 660








REAGENT R1 180 0 027 #

R2 60 0 027 #

R3 30 0 027 #

R4 0 0 027 #


AUTOCALIB.






BOTTLE BLANK


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name HbA1c 2 Assay Code (Mthd) 1 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 23 6 Assay Point 2 0 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 0 10 Wave Leng. (MAIN) 660 11 Sample Volume 4.0 12 R1 VOLUME 180 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 60 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 30 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Non-Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 34 Calib. Pos. 6 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 1000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 3521 10 02 10 September 2005/2

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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST HDL-C ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 240 – 20 – NO R 2 VOLUME (µl) 60 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 35 – 80 PANIC VALUE 1 - 180 INSTRUMENT FACTOR 1.00



TEST [HDL] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [HDL] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [600]





TEST [HDL] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [HDL] REPORT NAME [HDL] DATA MODE [Aktiv]

TEST NAME [HDL] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [HDL] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 3521 10 02 10 September 2005/2

BM / HITACHI 911


TEST HDL # TEST NAME HDL UNIT mg/dl

DATA MODE ON BOARD REPORT NAME HDL


b 0.0


AGE M F

- -

- -

35 - 80 35 - 80


1 - 180 -


LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST HDL


700 / 600








REAGENT R1 240 0 035 #

R2 0 0 035 #

R3 60 0 035 #

R4 0 0 035 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name HDL 2 Assay Code (Mthd) 2 point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 600 11 Sample Volume 3 12 R1 VOLUME 280 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 0 54 Expect. Value (L) 35 55 Expect. Value (H) 85 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7202 10 02 10 January 2009/4

IMMUNOGLOBULIN A FS Cat. No 1 7202.........


Immunoglobulin A 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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST IGA ASSAY CODE 2 – 24 – 42 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 350 – 20 – NO R 2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) – 570 CALIBR. METHOD 3 – 1 – 6 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. * - * STD.3 CONC.-POS. * – * STD.4 CONC.-POS. * – * STD.5 CONC.-POS. * – * STD.6 CONC.-POS. * – * SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE # – # PANIC VALUE 30 – 900 INSTRUMENT FACTOR 1.0



TEST [IGA] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [IGA] ASSAY/TIME/POINTS [2 point end] [10] [15] [26] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [570]





TEST [IGA] CALIBRATION TYPE [LOGIT/LOG 4P] [ ]

CALIBRATION POINTS

[6] SPAN POINT [6]




Range TEST [IGA] REPORT NAME [IGA] DATA MODE [Aktiv]

TEST NAME [IGA] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [IGA] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [#]


SAMPLE VOLUME [2] [2] [2] [2] [2] [2]



845 7202 10 02 10 January 2009/4

BM / HITACHI 911


TEST IGA # TEST NAME IGA UNIT mg/dl

DATA MODE ON BOARD REPORT NAME IGA


b 0.0


AGE M F

- -

- -

# - # # - #


30 - 900 -


LOT

QUALITATIVE

NO

(1) 0.0 # 2 0 0 # (1)

(2) * # 2 0 0 # (2)

(3) * # 2 0 0 # (3)

(4) * # 2 0 0 # (4)

(5) * # 2 0 0 # (5)

(6) * # 2 0 0 # (6)

TEST IGA


0 / 570








REAGENT R1 250 0 777 #

R2 0 0 777 #

R3 50 0 777 #

R4 0 0 777 #

CALIB. TYPE [LOGIT/LOG] 6 6 1

AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name IgA 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 30 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) - 10 Wave Leng. (MAIN) 570 11 Sample Volume 3 12 R1 VOLUME 350 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 1000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7239 10 02 10 October 2009/3

IMMUNOGLOBULIN E FS Cat. No 1 7239.........


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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST IGE ASSAY CODE 2 – 30 – 40 SAMPLE VOLUME (µl) 5 R 1 VOLUME (µl) 200 – 20 – NO R 2 VOLUME (µl) 100 – 20 – NO WAVELENGTH (nm) 800 – 570 CALIBR. METHOD 3 – 1 – 6 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. * - * STD.3 CONC.-POS. * – * STD.4 CONC.-POS. * – * STD.5 CONC.-POS. * – * STD.6 CONC.-POS. * – * SD LIMIT 999 DUPLICATE LIMIT 10000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) -32000 – 0 PROZONE LIMIT -32000 – 0 EXPECTED VALUE 0 – 100 PANIC VALUE 10 – 1000 INSTRUMENT FACTOR 1.0



TEST [IGE] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [IGE] ASSAY/TIME/POINTS [2 point end] [10] [18] [24] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [800] [570]




PROZONE LIMIT [-32000] [0] [Lower] Calibration

TEST [IGE] CALIBRATION TYPE [SPLINE] [ ]

CALIBRATION POINTS

[6] SPAN POINT [6]




Range TEST [IGE] REPORT NAME [IGE] DATA MODE [Aktiv]

TEST NAME [IGE] [] CONTROL INTERVAL UNIT [IU/ml] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [IGE] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [#]


SAMPLE VOLUME [5] [5] [5] [5] [5] [5]



845 7239 10 02 10 October 2009/3

BM / HITACHI 911


TEST IGE # TEST NAME IGE UNIT IU/ml

DATA MODE ON BOARD REPORT NAME IGE


b 0.0


AGE M F

- -

- -

0 - 100 0 - 100


10 - 1000 -


LOT

QUALITATIVE

NO

(1) 0.0 # 5 0 0 # (1)

(2) * # 5 0 0 # (2)

(3) * # 5 0 0 # (3)

(4) * # 5 0 0 # (4)

(5) * # 5 0 0 # (5)

(6) * # 5 0 0 # (6)

TEST IGE


800 / 570








REAGENT R1 200 0 432 #

R2 0 0 432 #

R3 100 0 432 #

R4 0 0 432 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name IgE 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 20 6 Assay Point 2 27 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) - 10 Wave Leng. (MAIN) 570 11 Sample Volume 5 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Small 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 100 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 1000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit -32000 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 100 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7212 10 02 10 January 2009/4

IMMUNOGLOBULIN G FS Cat. No 1 7212.........


Immunoglobulin G 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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST IGG ASSAY CODE 2 – 24 – 42 SAMPLE VOLUME (µl) 2 R 1 VOLUME (µl) 350 – 20 – NO R 2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) – 570 CALIBR. METHOD 3 – 1 – 6 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. * - * STD.3 CONC.-POS. * – * STD.4 CONC.-POS. * – * STD.5 CONC.-POS. * – * STD.6 CONC.-POS. * – * SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE # – # PANIC VALUE 175 – 3500 INSTRUMENT FACTOR 1.0



TEST [IGG] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [IGG] ASSAY/TIME/POINTS [2 point end] [10] [15] [26] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [570]





TEST [IGG] CALIBRATION TYPE [LOGIT/LOG 4P] [ ]

CALIBRATION POINTS

[6] SPAN POINT [6]




Range TEST [IGG] REPORT NAME [IGG] DATA MODE [Aktiv]

TEST NAME [IGG] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [IGG] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [#]


SAMPLE VOLUME [2] [2] [2] [2] [2] [2]



845 7212 10 02 10 January 2009/4

BM / HITACHI 911


TEST IGG # TEST NAME IGG UNIT mg/dl

DATA MODE ON BOARD REPORT NAME IGG


b 0.0


AGE M F

- -

- -

# - # # - #


175 - 3500 -


LOT

QUALITATIVE

NO

(1) 0.0 # 2 0 0 # (1)

(2) * # 2 0 0 # (2)

(3) * # 2 0 0 # (3)

(4) * # 2 0 0 # (4)

(5) * # 2 0 0 # (5)

(6) * # 2 0 0 # (6)

TEST IGG


0 / 570








REAGENT R1 350 0 779 #

R2 0 0 779 #

R3 70 0 779 #

R4 0 0 779 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name IgG 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 30 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) - 10 Wave Leng. (MAIN) 570 11 Sample Volume 2 12 R1 VOLUME 350 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 1000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7222 10 02 10 January 2009/4

IMMUNOGLOBULIN M FS Cat. No 1 7222.........


Immunoglobulin M 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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST IGM ASSAY CODE 2 – 16 – 42 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 350 – 20 – NO R 2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) – 405 CALIBR. METHOD 3 – 1 – 6 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. * - * STD.3 CONC.-POS. * – * STD.4 CONC.-POS. * – * STD.5 CONC.-POS. * – * STD.6 CONC.-POS. * – * SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE # – # PANIC VALUE 25 – 800 INSTRUMENT FACTOR 1.0



TEST [IGM] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [IGM] ASSAY/TIME/POINTS [2 point end] [10] [10] [26] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [415]





TEST [IGM] CALIBRATION TYPE [LOGIT/LOG 4P] [ ]

CALIBRATION POINTS

[6] SPAN POINT [6]




Range TEST [IGM] REPORT NAME [IGM] DATA MODE [Aktiv]

TEST NAME [IGM] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [IGM] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [#]


SAMPLE VOLUME [2] [2] [2] [2] [2] [2]



845 7222 10 02 10 January 2009/4

BM / HITACHI 911


TEST IGM # TEST NAME IGM UNIT mg/dl

DATA MODE ON BOARD REPORT NAME IGM


b 0.0


AGE M F

- -

- -

# - # # - #


25 - 800 -


LOT

QUALITATIVE

NO

(1) 0.0 # 2 0 0 # (1)

(2) * # 2 0 0 # (2)

(3) * # 2 0 0 # (3)

(4) * # 2 0 0 # (4)

(5) * # 2 0 0 # (5)

(6) * # 2 0 0 # (6)

TEST IGM


0 / 415








REAGENT R1 250 0 789 #

R2 0 0 789 #

R3 50 0 789 #

R4 0 0 789 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name IgM 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 13 6 Assay Point 2 30 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) - 10 Wave Leng. (MAIN) 415 11 Sample Volume 3 12 R1 VOLUME 350 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 1000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1911 10 02 10 August 2008/4

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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST IRON ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 15 R 1 VOLUME (µl) 240 – 20 – NO R 2 VOLUME (µl) 60 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 23 – 168 PANIC VALUE 5 - 1000 INSTRUMENT FACTOR 1.0



TEST [IRON] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [IRON] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [600]





TEST [IRON] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [IRON] REPORT NAME [Iron] DATA MODE [Aktiv]

TEST NAME [IRON] [] CONTROL INTERVAL UNIT [µg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [IRON] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [15] [15] [1] [1] [1] [1]



845 1911 10 02 10 August 2008/4

BM / HITACHI 911


TEST IRON # TEST NAME IRON UNIT µg/dl

DATA MODE ON BOARD REPORT NAME Iron


b 0.0


AGE M F

- -

- -

35 - 155 23 - 165


5 - 1000 -


LOT

QUALITATIVE

NO

(1) 0 # 15 0 0 # (1)

(2) * # 15 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST IRON


700 / 600








REAGENT R1 240 0 661 #

R2 0 0 661 #

R3 60 0 661 #

R4 0 0 661 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name Iron 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 600 11 Sample Volume 15 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 23 55 Expect. Value (H) 168 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 4001 10 02 10 August 2008/4

LACTATE FS Cat. No 1 4001.........

Notes 1. Please refer to the package insert for Lactate FS for



5 days provided that contamination and evaporation are avoided.



HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST LAC ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 4 R 1 VOLUME (µl) 240 – 100 – 0 R 2 VOLUME (µl) 60 – 20 – 0 WAVELENGTH (nm) 800 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # PANIC VALUE 1 – 120 INSTRUMENT FACTOR 1.0



TEST [LAC] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [LAC] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [800] [340]





TEST [LAC] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [LAC] REPORT NAME [Lactate] DATA MODE [Aktiv]

TEST NAME [LAC] [] CONTROL INTERVAL UNIT [mg/dll] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]




SAMPLE VOLUME [4] [4] [1] [1] [1] [1]



845 4001 10 02 10 August 2008/4

BM / HITACHI 911


TEST LAC # TEST NAME LAC UNIT mg/dl

DATA MODE ON BOARD REPORT NAME Lactate


b 0.0


AGE M F

- -

- -

# - # # - #


1 - 120 -


LOT

QUALITATIVE

NO

(1) 0 # 4 0 0 # (1)

(2) * # 4 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST LAC


800 / 340






ABS. LIMIT 32000 32000 1:INCREASE

PROZONE LIMIT 32000 32000 1:HIGHER

REAGENT R1 240 0 040 #

R2 0 0 040 #

R3 60 0 040 #

R4 0 0 040 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name LAC 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 800 10 Wave Leng. (MAIN) 340 11 Sample Volume 4 12 R1 VOLUME 280 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.00 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 200 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0.0 55 Expect. Value (H) 1.0 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 4201 10 02 10 October 2009/3

LDH FS DGKC Cat. No 1 4201.........

Notes 1. Please refer to the package insert for LDH DGKC






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST LDH ASSAY CODE 5 – 30 – 45 SAMPLE VOLUME (µl) 5 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 405 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 6500 – 1 PROZONE LIMIT 0 EXPECTED VALUE 225 – 480 PANIC VALUE 0 - 1200 INSTRUMENT FACTOR 1.0




TEST [LDH] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [LDH] ASSAY/TIME/POINTS [Rate A] [10] [20] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [415] [340]





TEST [LDH] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [LDH] REPORT NAME [LDH] DATA MODE [Aktiv]

TEST NAME [LDH] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [LDH] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [7] [7] [1] [1] [1] [1]



845 4201 10 02 10 October 2009/3

BM / HITACHI 911


TEST LDH # TEST NAME LDH UNIT U/L

DATA MODE ON BOARD REPORT NAME LDH


b 0.0


AGE M F

- -

- -

225 - 480 225 - 480


0 - 1200 -

STD CO

N

PO

S

S.VO

L.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 7 0 0 # (1)

(2) * # 7 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST LDH


415 / 340








REAGENT R1 200 0 122 #

R2 0 0 122 #

R3 50 0 122 #

R4 0 0 122 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name LDH 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 31 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 415 10 Wave Leng. (MAIN) 340 11 Sample Volume 5 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 6500 50 ABS Limit (D/I) Decrease 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 225 55 Expect. Value (H) 450 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 4211 10 02 10 October 2009/5

LDH FS IFCC Cat. No 1 4211.........

Notes 1. Please refer to the package insert for LDH FS IFCC






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST LDH ASSAY CODE 5 – 30 – 45 SAMPLE VOLUME (µl) 4 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 405 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 14000 – 0 PROZONE LIMIT 0 EXPECTED VALUE #– # PANIC VALUE 0 - 1200 INSTRUMENT FACTOR 1.0




TEST [LDH] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [LDH] ASSAY/TIME/POINTS [Rate A] [10] [20] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [415] [340]





TEST [LDH] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [LDH] REPORT NAME [LDH] DATA MODE [Aktiv]

TEST NAME [LDH] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [LDH] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [4] [4] [1] [1] [1] [1]



845 4211 10 02 10 October 2009/5

BM / HITACHI 911


TEST LDH # TEST NAME LDH UNIT U/L

DATA MODE ON BOARD REPORT NAME LDH


b 0.0


AGE M F

- -

- -

# - # # - #


0 - 1200 -

STD CO

N

PO

S

S.VO

L.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 4 0 0 # (1)

(2) * # 4 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST LDH


415 / 340






ABS. LIMIT 14000] 2:INCREASE


REAGENT R1 200 0 080 #

R2 0 0 080 #

R3 50 0 080 #

R4 0 0 080 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name LDH 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 31 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 415 10 Wave Leng. (MAIN) 340 11 Sample Volume 5 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 14000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 135 55 Expect. Value (H) 225 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 4121 10 02 10 September 2005/2

LDL-C SELECT FS Cat. No 1 4121.........

Notes 1. Please refer to the package insert for LDL-C Select






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST LDL-C ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 240 – 20 – NO R 2 VOLUME (µl) 60 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 130 PANIC VALUE 1 - 400 INSTRUMENT FACTOR 1.00



TEST [LDL] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [LDL] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [600]





TEST [LDL] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [LDL] REPORT NAME [LDL] DATA MODE [Aktiv]

TEST NAME [LDL] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [LDL] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 4121 10 02 10 September 2005/2

BM / HITACHI 911


TEST LDL # TEST NAME LDL UNIT mg/dl

DATA MODE ON BOARD REPORT NAME LDL Cholesterol


b 0.0


AGE M F

- -

- -

0 - 130 0 - 130


1 - 400 -

STD CO

N

PO

S

S.VO

L.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST LDL


700 / 600








REAGENT R1 240 0 059 #

R2 0 0 059 #

R3 60 0 059 #

R4 0 0 059 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name LDL 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 600 11 Sample Volume 3 12 R1 VOLUME 280 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 0 54 Expect. Value (L) 0 55 Expect. Value (H) 130 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 4321 10 02 10 August 2008/4

LIPASE DC FS Cat. No 1 4321.........

Notes 1. Please refer to the package insert for Lipase DC FS







HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST LIP ASSAY CODE 5 – 32 – 39 SAMPLE VOLUME (µl) 6 R 1 VOLUME (µl) 280 – 20 – NO R 2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 700 – 570 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 32000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 60 PANIC VALUE 0 - 300 INSTRUMENT FACTOR 1.0




TEST [LIP] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [LIP] ASSAY/TIME/POINTS [Rate A] [10] [21] [25] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [570]





TEST [LIP] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [LIP] REPORT NAME [LIPASE] DATA MODE [Aktiv]

TEST NAME [LIP] [] CONTROL INTERVAL UNIT [U/l] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [LIP] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [5] [5] [1] [1] [1] [1]



845 4321 10 02 10 August 2008/4

BM / HITACHI 911


TEST LIP # TEST NAME LIP UNIT U/L

DATA MODE ON BOARD REPORT NAME Lipase


b 0.0


AGE M F

- -

- -

0 - 60 0 - 60


0 - 300 -


LOT

QUALITATIVE

NO

(1) 0.0 # 5 0 0 # (1)

(2) * # 5 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST LIP


800 / 570








REAGENT R1 200 0 731 #

R2 0 0 731 #

R3 50 0 731 #

R4 0 0 731 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name LIP 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 23 6 Assay Point 2 27 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 570 11 Sample Volume 6 12 R1 VOLUME 280 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 200 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 32000 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 60 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7139 10 02 10 September 2009/5

Lp(a) 21 FS Cat. No 1 7139.........

Notes 1. Please refer to the package insert for Lp (a) 21 FS







HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST LPA ASSAY CODE 2 – 31 – 50 SAMPLE VOLUME (µl) 5 R 1 VOLUME (µl) 200 – 20 – NO R 2 VOLUME (µl) 100 – 20 – NO WAVELENGTH (nm) 0 – 700 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. * – * SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 0 – 30 PANIC VALUE 3 - 130 INSTRUMENT FACTOR 1.0



TEST [LPA] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [LPA] ASSAY/TIME/POINTS [2 point end] [10] [19] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [700]




PROZONE LIMIT [-32000] [0] [lower] Calibration

TEST [LPA] CALIBRATION TYPE [Spline] [ ]

CALIBRATION POINTS

[6] SPAN POINT [6]



2-POINT [0] St SENSITIVITY LIMIT 0] - [0] FULL [0] St S1 ABS LIMIT [-32000] - [32000]

Range TEST [LPA] REPORT NAME [Lipoprotein a] DATA MODE [Aktiv]

TEST NAME [LPA] [] CONTROL INTERVAL UNIT [#] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [LPA] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [#]


SAMPLE VOLUME [5] [5] [5] [5] [5] [5]



845 7139 10 02 10 September 2009/5

BM / HITACHI 911


TEST LPA # TEST NAME LPA UNIT #

DATA MODE ON BOARD REPORT NAME Lp(a)


b 0.0


AGE M F

- -

- -

0 - 30 0 - 30


3 - 130 -


LOT

QUALITATIVE

NO

(1) 0.0 # 5 0 0 # (1)

(2) * # 5 0 0 # (2)

(3) * # 5 0 0 # (3)

(4) * # 5 0 0 # (4)

(5) * # 5 0 0 # (5)

(6) * # 5 0 0 # (6)

TEST LPA


0 / 700








REAGENT R1 200 0 242 #

R2 0 0 242 #

R3 100 0 242 #

R4 0 0 242 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name LPA 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 0 10 Wave Leng. (MAIN) 700 11 Sample Volume 5 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Small 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 100 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Spline 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 50.0 45 Duplicate Limit 32000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 30 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 4610 10 02 10 August 2008/4

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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST MG ASSAY CODE 1 – 50 – 0 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 250 – 20 – NO R 2 VOLUME (µl) 0 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 1.8 – 2.6 PANIC VALUE 0.05 –5.0 INSTRUMENT FACTOR 1.0



TEST [MG] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [MG] ASSAY/TIME/POINTS [1 point] [10] [31] [0] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [546]





TEST [MG] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [MG] REPORT NAME [Magnesium] DATA MODE [Aktiv]

TEST NAME [MG] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [MG] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 4610 10 02 10 August 2008/4

BM / HITACHI 911


TEST MG # TEST NAME MG UNIT mg/dl

DATA MODE ON BOARD REPORT NAME Magnesium


b 0.0


AGE M F

- -

- -

1.8 - 2.6 1.8 - 2.6


0.0 - 5.0 -


LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST MG


700 / 546








REAGENT R1 250 0 693 #

R2 0 0 693 #

R3 0 0 693 #

R4 0 0 693 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name MAG 2 Assay Code (Mthd) 1 Point 3 Assay Code (2. Test) 0 4 Reaction Time 5 5 Assay Point 1 5 6 Assay Point 2 17 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 546 11 Sample Volume 3 12 R1 VOLUME 300 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 0 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 1.9 55 Expect. Value (H) 2.5 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 5211 10 02 10 January 2009/5

PHOSPHATE FS Cat. No 1 5211.........

Notes 1. Please refer to the package insert for Phosphate FS






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST PHOS ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 240 – 100 – 0 R 2 VOLUME (µl) 60 – 20 – 0 WAVELENGTH (nm) 660 – 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 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 PANIC VALUE 0.2 – 20.0 INSTRUMENT FACTOR 1.0



TEST [PHOS] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [PHOS] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [660] [340]





TEST [PHOS] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [PHOS] REPORT NAME [Phosphate] DATA MODE [Aktiv]

TEST NAME [PHOS] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [PHOS] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 5211 10 02 10 January 2009/5

BM / HITACHI 911


TEST PHOS # TEST NAME PHOS UNIT mg/dl

DATA MODE ON BOARD REPORT NAME Phosphate


b 0.0


AGE M F

- -

- -

2.6 - 4.5 1.8 - 2.6


0.2 - 40.0 -


LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST PHOS


660 / 340






ABS. LIMIT 0 32000 2:INCREASE

PROZONE LIMIT 32000 0 1:HIGHER

REAGENT R1 240 0 394] #

R2 0 0 394] #

R3 60 0 394] #

R4 0 0 394] #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name PHOS 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 660 10 Wave Leng. (MAIN) 340 11 Sample Volume 3 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 200 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 1.8 55 Expect. Value (H) 4.5 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7022 10 02 10 August 2008/6

RHEUMATOID FACTOR FS Cat. No 1 7022.........

Notes 1. Please refer to the package insert for Rheumatoid

Factor 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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST RF ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 15 R 1 VOLUME (µl) 250 – 20 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 700 – 340 CALIBR. METHOD 3 – 4 – 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. * – * SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 0 – 15 PANIC VALUE 0 - 500 INSTRUMENT FACTOR 1.0



TEST [RF] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [RF] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [340]





TEST [RF] CALIBRATION TYPE [Spline] [ ]

CALIBRATION POINTS

[6] SPAN POINT [3]




Range TEST [RF] REPORT NAME [RF] DATA MODE [Aktiv]

TEST NAME [RF] [] CONTROL INTERVAL UNIT [IU/ml] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [RF] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [#]


SAMPLE VOLUME [15] [15] [15] [15] [15] [15]



845 7022 10 02 10 August 2008/6

BM / HITACHI 911


TEST RF # TEST NAME RF UNIT IU/ml

DATA MODE ON BOARD REPORT NAME RF


b 0.0


AGE M F

- -

- -

0 - 15 0 - 15


0 - 500 -


LOT

QUALITATIVE

NO

(1) 0.0 # 15 0 0 # (1)

(2) * # 15 0 0 # (2)

(3) * # 15 0 0 # (3)

(4) * # 15 0 0 # (4)

(5) * # 15 0 0 # (5)

(6) * # 15 0 0 # (6)

TEST RF


700 / 340








REAGENT R1 250 0 017 #

R2 0 0 017 #

R3 50 0 017 #

R4 0 0 017 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name RF 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 340 11 Sample Volume 15 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Logit-Log 4P 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 2500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) 0 55 Expect. Value (H) 15 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 2311 10 02 10 March 2009/4

TOTAL PROTEIN FS Cat. No 1 2311.........

Notes 1. Please refer to the package insert for Total Protein






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST TP ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 6 R 1 VOLUME (µl) 240 – 100 – NO R 2 VOLUME (µl) 60 – 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 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 PANIC VALUE 0.05 – 15.0 INSTRUMENT FACTOR 1.0



TEST [TP] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [TP] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [546]





TEST [TP] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [TP] REPORT NAME [Total Protein] DATA MODE [Aktiv]

TEST NAME [TP] [] CONTROL INTERVAL UNIT [g/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [TP] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [6] [6] [1] [1] [1] [1]



845 2311 10 02 10 March 2009/4

BM / HITACHI 911


TEST TP # TEST NAME TP UNIT g/dl

DATA MODE ON BOARD REPORT NAME Total Protein


b 0.0


AGE M F

- -

- -

6.6 - 8.8 6.6 - 8.8


0.05 - 15.0 -


LOT

QUALITATIVE

NO

(1) 0.0 # 6 0 0 # (1)

(2) * # 6 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST TP

ASSAY CODE 2 point end 10 WAVELG

H

(SUB / MAIN)

0 / 546








REAGENT R1 240 0 376 #

R2 0 0 376 #

R3 60 0 376 #

R4 0 0 376 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name TP 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 546 11 Sample Volume 6 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size lSmall 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 6.6 55 Expect. Value (H) 8.7 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 0210 10 52 10 May 2009/4

TOTAL PROTEIN UC FS 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






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST TPU ASSAY CODE 1 – 50 – 0 SAMPLE VOLUME (µl) 6 R 1 VOLUME (µl) 300 – 20 – NO R 2 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 SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 24 – 141 PANIC VALUE 20 – 3000 INSTRUMENT FACTOR 1.0



TEST [TPU] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [TPU] ASSAY/TIME/POINTS [1 point] [10] [31] [0] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [600]





TEST [TPU] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [TPU] REPORT NAME [TPU] DATA MODE [Aktiv]

TEST NAME [TPU] [] CONTROL INTERVAL UNIT [mg/L] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [TPU] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [5] [5] [1] [1] [1] [1]



845 0210 10 52 10 May 2009/4

BM / HITACHI 911


TEST TPU # TEST NAME TPU UNIT mg/L

DATA MODE ON BOARD REPORT NAME Urine TP


b 0.0


AGE M F

- -

- -

24 - 141 24 - 141


24 - 3000 -


LOT

QUALITATIVE

NO

(1) 0 # 5 0 0 # (1)

(2) * # 5 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST TPU


700 / 600








REAGENT R1 250 0 769 #

R2 0 0 769 #

R3 0 0 769 #

R4 0 0 769 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name TPU 2 Assay Code (Mthd) 1 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 35 6 Assay Point 2 0 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 600 11 Sample Volume 5 12 R1 VOLUME 250 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 0 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 40 55 Expect. Value (H) 80 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 7252 10 02 10 September 2005/2

TRANSFERRIN FS Cat. No 1 7252.........

Notes 1. Please refer to the package insert for Transferrin FS






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST TRF ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 350 – 20 – NO R 2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) – 570 CALIBR. METHOD 3 – 1 – 6 STD.1 CONC.-POS. 0 – 1 STD.2 CONC.-POS. * - * STD.3 CONC.-POS. * – * STD.4 CONC.-POS. * – * STD.5 CONC.-POS. * – * STD.6 CONC.-POS. * – * SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE # – # PANIC VALUE 50 – 800 INSTRUMENT FACTOR 1.0



TEST [TRF] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [TRF] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [0] [570]





TEST [TRF] CALIBRATION TYPE [LOGIT/LOG 4P] [ ]

CALIBRATION POINTS

[6] SPAN POINT [6]




Range TEST [TRF] REPORT NAME [Transferrin] DATA MODE [Aktiv]

TEST NAME [TRF] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [TRF] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [#] [#] [#] [#]


SAMPLE VOLUME [2] [2] [2] [2] [2] [2]



845 7252 10 02 10 September 2005/2

BM / HITACHI 911


TEST TRF # TEST NAME TRF UNIT mg/dl

DATA MODE ON BOARD REPORT NAME TRF


b 0.0


AGE M F

- -

- -

# - # # - #


50 - 800 -

STD CON POS S.VOL

.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 2 0 0 # (1)

(2) * # 2 0 0 # (2)

(3) * # 2 0 0 # (3)

(4) * # 2 0 0 # (4)

(5) * # 2 0 0 # (5)

(6) * # 2 0 0 # (6)

TEST TRF


0 / 570








REAGENT R1 250 0 216 #

R2 0 0 216 #

R3 50 0 216 #

R4 0 0 216 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name TRF 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) - 10 Wave Leng. (MAIN) 570 11 Sample Volume 3 12 R1 VOLUME 350 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 70 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Line-graph 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 # 28 Calib. Pos. 3 # 29 Calib. Conc. 4 # 30 Calib. Pos. 4 # 31 Calib. Conc. 5 # 32 Calib. Pos. 5 # 33 Calib. Conc. 6 # 34 Calib. Pos. 6 # 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 999 45 Duplicate Limit 1000 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 32000 52 Prz. Limit (U/D) Upper 53 Prz. (End Point) 35 54 Expect. Value (L) # 55 Expect. Value (H) # 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 5710 10 02 10 September 2005/2

TRIGLYCERIDES FS Cat. No 1 5710.........

Notes 1. Please refer to the package insert for Triglycerides






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST TRIG ASSAY CODE 1 – 50 – 0 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 300 – 100 – NO R 2 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 200 PANIC VALUE 1 - 1000 INSTRUMENT FACTOR 1.0



TEST [TRIG] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [TRIG] ASSAY/TIME/POINTS [1 point] [10] [31] [0] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [505]





TEST [TRIG] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [TRIG] REPORT NAME [Triglycerides] DATA MODE [Aktiv]

TEST NAME [TRIG] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [TRIG] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [3] [3] [1] [1] [1] [1]



845 5710 10 02 10 September 2005/2

BM / HITACHI 911


TEST TRIG # TEST NAME TRIG UNIT mg/dl

DATA MODE ON BOARD REPORT NAME TRIGLCERIDES


b 0.0


AGE M F

- -

- -

0 - 200 0 - 200


1 - 1000

-


LOT

QUALITATIVE

NO

(1) 0.0 # 3 0 0 # (1)

(2) * # 3 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST TRIG


700 / 505








REAGENT R1 250 0 006 #

R2 0 0 006 #

R3 0 0 006 #

R4 0 0 006 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name TRIG 2 Assay Code (Mthd) 1 Point 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 35 6 Assay Point 2 0 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 505 11 Sample Volume 3.0 12 R1 VOLUME 300 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 0 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 500 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 50 55 Expect. Value (H) 200 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 1921 10 02 10 September 2009/4

UIBC FS Cat. No 1 1921.........

Notes 1. Please refer to the package insert for UIBC FS for



6 days provided that contamination and evaporation are avoided.



HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST UIBC ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 18 R 1 VOLUME (µl) 240 – 20 – NO R 2 VOLUME (µl) 60 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 120 – 470 PANIC VALUE 6 - 750 INSTRUMENT FACTOR 1.0



TEST [UIBC] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [UIBC] ASSAY/TIME/POINTS [2 point end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [600]





TEST [UIBC] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [UIBC] REPORT NAME [UIBC] DATA MODE [Aktiv]

TEST NAME [UIBC] [] CONTROL INTERVAL UNIT [µg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [UIBC] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [18] [18] [1] [1] [1] [1]



845 1921 10 02 10 September 2009/4

BM / HITACHI 911


TEST UIBC # TEST NAME UIBC UNIT µg/dl

DATA MODE ON BOARD REPORT NAME UIBC


b 0.0


AGE M F

- -

- -

120 - 470 120 - 470


6 - 750 -


LOT

QUALITATIVE

NO

(1) 0 # 18 0 0 # (1)

(2) * # 18 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST UIBC


700 / 600








REAGENT R1 240 0 785 #

R2 0 0 785 #

R3 60 0 785 #

R4 0 0 785 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name UIBC 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 600 11 Sample Volume 18 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 120 55 Expect. Value (H) 470 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 3101 10 02 10 September 2006/3

UREA FS Cat. No 1 3101.........

Notes 1. Please refer to the package insert for Urea FS for






HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST UREA ASSAY CODE 5 – 30 – 35 SAMPLE VOLUME (µl) 3 R 1 VOLUME (µl) 200 – 100 – NO R 2 VOLUME (µl) 50 – 20 – NO WAVELENGTH (nm) 405 – 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 SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS.LIMIT(INC/DEC) 8000 – 1 PROZONE LIMIT 0 EXPECTED VALUE 17 – 43 PANIC VALUE 2 - 300 INSTRUMENT FACTOR 1.0



TEST [UREA] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [UREA] ASSAY/TIME/POINTS [Rate A] [10] [18] [22] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [415] [340]





TEST [UREA] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [UREA] REPORT NAME [Urea] DATA MODE [Aktiv]

TEST NAME [UREA] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [UREA] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [2] [2] [1] [1] [1] [1]



845 3101 10 02 10 September 2006/3

BM / HITACHI 911


TEST UREA # TEST NAME UREA UNIT mg/dl

DATA MODE ON BOARD REPORT NAME Urea


b 0.0


AGE M F

- -

- -

17 - 43 17 - 43


2 - 300 -

STD CON POS S.VOL

.

PRE. DIL. VOL CODE

LOT

QUALITATIVE

NO

(1) 0.0 # 2 0 0 # (1)

(2) * # 2 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST UREA


415 / 340








REAGENT R1 200 0 392 #

R2 0 0 392 #

R3 50 0 392 #

R4 0 0 392 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name UREA 2 Assay Code (Mthd) Rate A 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 21 6 Assay Point 2 24 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 415 10 Wave Leng. (MAIN) 340 11 Sample Volume 2.5 12 R1 VOLUME 200 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 50 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 8000 50 ABS Limit (D/I) Decrease 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 10 55 Expect. Value (H) 50 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 3021 10 02 10 March 2009/3

URIC ACID FS TBHBA Cat. No 1 3021.........

Notes 1. Please refer to the package insert for Uric Acid FS

TBHBA 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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST UA ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 5 R 1 VOLUME (µl) 240 - 100 - NO R 2 VOLUME (µl) 60 - 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 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 PANIC VALUE 0.07 – 20.0 INSTRUMENT FACTOR 1.0



TEST [UA] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [UA] ASSAY/TIME/POINTS [2-point-end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [546]





TEST [UA] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [UA] REPORT NAME [Uric Acid] DATA MODE [Aktiv]

TEST NAME [UA] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [UA] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [6] [6] [1] [1] [1] [1]



845 3021 10 02 10 March 2009/3

BM / HITACHI 911


TEST UA # TEST NAME UA UNIT mg/dl

DATA MODE ON BOARD REPORT NAME Uric Acid


b 0.0


AGE M F

- -

- -

3.6 - 8.2 2.3 - 6.1


0.07 - 20.0 -


LOT

QUALITATIVE

NO

(1) 0.0 # 6 0 0 # (1)

(2) * # 6 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST UA


H

(SUB / MAIN)

700 / 546








REAGENT R1 240 0 398 #

R2 0 0 398 #

R3 60 0 398 #

R4 0 0 398 #


AUTOCALIB.






BOTTLE NO

# Data entry by the user * Enter calibration or standard value ## Enter the next code ## Enter the next code

BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name UA 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 505 11 Sample Volume 4 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. 0 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 2.4 55 Expect. Value (H) 7.0 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


845 3001 10 02 10 March 2009/4

URIC ACID FS TOOS Cat. No 1 3001.........

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





HITACHI 717

Chemistry settings

PROGRAM 2: CHEMISTRY PARAMETERS TEST UA ASSAY CODE 2 – 24 – 50 SAMPLE VOLUME (µl) 5 R 1 VOLUME (µl) 240 – 100 – NO R 2 VOLUME (µl) 60 – 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 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 PANIC VALUE 0.3 – 20.0 INSTRUMENT FACTOR 1.0



TEST [UA] ANALYZER CYCLE TIME [10 sec] DILUENT [water] [0] TEST NAME [UA] ASSAY/TIME/POINTS [2-point-end] [10] [15] [31] [0] [0] APPL.CODE [#] WAVELENGTH (SUB/MAIN) [700] [546]





TEST [UA] CALIBRATION TYPE [Linear] [ ]

CALIBRATION POINTS

[2] SPAN POINT [2]




Range TEST [UA] REPORT NAME [Uric Acid] DATA MODE [Aktiv]

TEST NAME [UA] [] CONTROL INTERVAL UNIT [mg/dl] INSTRUMENT FACTOR (y=ax+b) APPL. CODE [#] a= [1.0] b= [0.00]


TEST [UA] (STANDARD) (1) (2) (3) (4) (5) (6) CALIB. CODE [#] [#] [0] [0] [0] [0]


SAMPLE VOLUME [5] [5] [1] [1] [1] [1]



845 3001 10 02 10 March 2009/4

BM / HITACHI 911


TEST UA # TEST NAME UA UNIT mg/dl

DATA MODE ON BOARD REPORT NAME Uric Acid


b 0.0


AGE M F

- -

- -

3.6 - 8.2 2.3 - 6.1


0.3 - 20.0 -


LOT

QUALITATIVE

NO

(1) 0.0 # 5 0 0 # (1)

(2) * # 5 0 0 # (2)

(3) (3)

(4) (4)

(5) (5)

(6) (6)

TEST UA


H

(SUB / MAIN)

700 / 546








REAGENT R1 240 0 397 #

R2 0 0 397 #

R3 60 0 397 #

R4 0 0 397 #


AUTOCALIB.






BOTTLE NO


BM / HITACHI 902

INSTRUMENT SETTINGS

No. <Chemistry> 1 Test Name UA 2 Assay Code (Mthd) 2 Point End 3 Assay Code (2. Test) 0 4 Reaction Time 10 5 Assay Point 1 17 6 Assay Point 2 35 7 Assay Point 3 0 8 Assay Point 4 0 9 Wave Leng. (SUB) 700 10 Wave Leng. (MAIN) 546 11 Sample Volume 5 12 R1 VOLUME 240 13 R1 Pos. # 14 R1 Bottle Size Large 15 R2 VOLUME 0 16 R2 Pos. 0 17 R2 Bottle Size Small 18 R3 VOLUME 60 19 R3 Pos. # 20 R3 Bottle Size Small 21 Calib. Type (Type) Linear 22 Calib. Type (Wght) 0 23 Calib. Conc. 1 0.0 24 Calib. Pos. 1 # 25 Calib. Conc. 2 # 26 Calib. Pos. 2 # 27 Calib. Conc. 3 0 28 Calib. Pos. 3 0 29 Calib. Conc. 4 0 30 Calib. Pos. 4 0 31 Calib. Conc. 5 0 32 Calib. Pos. 5 0 33 Calib. Conc. 6 0 34 Calib. Pos. 6 0 35 S 1 ABS. 0 36 K Factor 10000 37 K 2 Factor 10000 38 K 3 Factor 10000 39 K 4 Factor 10000 40 K 5 Factor 10000 41 A Factor 0 42 B Factor 0 43 C Factor 0 44 SD Limit 0.1 45 Duplicate Limit 300 46 Sens. Limit 0 47 S 1 ABS Limit (L) -32000 48 S 1 ABS Limit (H) 32000 49 ABS Limit 0 50 ABS Limit (D/I) Increase 51 Prz. Limit 0 52 Prz. Limit (U/D) Lower 53 Prz. (End Point) 35 54 Expect. Value (L) 2.4 55 Expect. Value (H) 7.0 56 Instr. Fact. (a) 1 57 Instr. Fact. (b) 0 58 Key Setting #


cholinesterase fs hitachi 717 - grupo biosys · hitachi 717 chemistry settings temperature: ......

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