HITACHI 917 ALBUMIN FS - AsteriscoHITACHI 917 ALBUMIN FS Chemistry parameters Analysis Test / Type...

845 0220 10 02 09

August 2008/6

HITACHI 917 Chemistry parameters

Analysis

Test / Type ALB Ser/Pl

Assay / Time / Point 1 Point End A 3 A 7 0 0 0

Wave (2nd

/Primary) 700 A 600 A

S.Vol (Normal) 2 0 0

S.Vol (Decrease) 2 0 0

S.Vol (Increase) 4 0 0

Diluent 00951 99 Timing

Reagent (R1) T1 180 0 413 0 R1

Reagent (R2) T2 0 0 413 0 R2

Reagent (R3) T3 0 0 413 0 R3

Reagent (R4) T4 0 0 413 0

Abs. Limit 12000 Increase A

Prozone Limit 32000 0 Upper A

Cell Detergent Detergent 1 A

Calibration

Calibration type Linear A A

Point 2 Span Point 2

Weight 0

Autocalibration Time Out Change Over

Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1

Duplicate limit 10 % 200 Abs

Sensitivity limit -99999 999999

S1 Abs limit -32000 32000

Range

Application Code 413 Unit g/l A

Report Name Albumin

Data Mode On Board A

Control Interval 1000

Instrument Factor (Y=aX+b) a= 1.0 b= 0.0

Technical Limit 0 60

Repeat Limit 0 60

Expected Value Qualitative

(Male) 1 Y A 35 50 Cancel A

100 Y A 35 50 (1) 0

35 50 (2) 0

(Female) 1 Y A 35 50 (3) 0

100 Y A 35 50 (4) 0

35 50 (5) 0

(Default) Male A Range3 A (6) 0

Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #

Concentration 0 * Position

Sample Volume 2 2

Diluent S.Vol 0 0

Diluent Volume 0 0

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

ALBUMIN FS

Order information

Cat. No. 1 0220 .. .. …

Notes

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

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

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

Reference Ranges Literature

2. The stability of the reagent on board the analyser is 6

weeks provided that contamination and evaporation are avoided.

3. Manufactured by

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

**This application was set up and evaluated at DiaSys. It is

based on the standard equipment at that time and does not

apply to any equipment modifications undertaken by the

manufacturer or by other persons.

845 0501 10 02 09 September 2009/5


Analysis

Test / Type AMY Ser/Pl

Assay / Time / Point Rate A A 10 A 26 33 0 0

Wave (2nd






Reagent (R1) T1 160 0 570 0 R1

Reagent (R2) T2 0 0 570 0 R2

Reagent (R3) T3 40 0 570 0 R3

Reagent (R4) T4 0 0 570 0


Prozone Limit 32000 0 Lower A


Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range

Application Code 570 Unit U/l A

Report Name Amylase





Repeat Limit 0 2000


(Male) Y A Cancel A

Y A (1) 0

# # (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 3 3

Diluent S.Vol 0 0

Diluent Volume 0 0


-AMYLASE CC FS

Order information

Cat. No. 1 0501 .. .. …

Notes

1. Please refer to the package insert for -Amylase CC FS

for detailed information about the test on the following:




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






845 7102 10 02 09 November 2006/4


Analysis

Test / Type APOA Ser/Pl


Wave (2nd






Reagent (R1) T1 200 0 168 0 R1

Reagent (R2) T2 0 0 168 0 R2

Reagent (R3) T3 40 0 168 0 R3

Reagent (R4) T4 0 0 168 0




Calibration

Calibration type Logt-Log-3P A A


Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 999



S1 Abs limit -32000 32000

Range

Application Code 168 Unit mg/dl A

Report Name APOA1




Technical Limit 0.2 250

Repeat Limit 0.2 250


(Male) Y A Cancel A

Y A (1) 0

(2) 0

(Female) Y A (3) 0

Y A (4) 0

110 170 (5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 # # #

Concentration 0.0 * * * Position

Sample Volume 2 2 2 2

Diluent S.Vol 0 0 0 0

Diluent Volume 0 0 0 0


APOLIPOPROTEIN A1 FS

Order information

Cat. No. 1 7102 .. .. …

Notes

1. Please refer to the package insert for

Apolipoprotein A1 FS for detailed information about the test on the following:






3. Manufactured by






845 7112 10 02 09 November 2006/4


Analysis

Test / Type APOB Ser/Pl


Wave (2nd






Reagent (R1) T1 200 0 151 0 R1

Reagent (R2) T2 0 0 151 0 R2

Reagent (R3) T3 40 0 151 0 R3

Reagent (R4) T4 0 0 151 0




Calibration

Calibration type Logt-Log-3P A A


Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 999



S1 Abs limit -32000 32000

Range


Report Name APOB







(Male) Y A Cancel A

Y A (1) 0

(2) 0

(Female) Y A (3) 0

Y A (4) 0

80 155 (5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 # # #

Concentration 0.0 * * * Position

Sample Volume 2 2 2 2

Diluent S.Vol 0 0 0 0

Diluent Volume 0 0 0 0


APOLIPOPROTEIN B FS

Order information

Cat. No 1 7112 .. .. …

Notes


Apolipoprotein B FS for detailed information about the test on the following:






3. Manufactured by






845 0950 10 02 09 November 2006/5


Analysis

Test / Type CO2 Ser/Pl


Wave (2nd






Reagent (R1) T1 200 0 156 0 R1

Reagent (R2) T2 0 0 156 0 R2

Reagent (R3) T3 0 0 156 0 R3

Reagent (R4) T4 0 0 156 0

Abs. Limit 0 Decrease A

Prozone Limit -32000 0 Lower A


Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range

Application Code 156 Unit mmol/l A

Report Name Bicarbonate




Technical Limit 0 50.0

Repeat Limit 0 50.0


(Male) Y A Cancel A

Y A (1) 0

22 29 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #

Concentration 0.0 * Position

Sample Volume 2 2

Diluent S.Vol 0 0

Diluent Volume 0 0


BICARBONATE FS

Order information

Cat. No. 1 0950 .. .. …

Notes


Bicarbonate FS for detailed information about the test on the following:






3. Manufactured by






845 0821 10 02 09 March 2004/5


Analysis

Test / Type DBIL Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 294 0 R1

Reagent (R2) T2 0 0 294 0 R2

Reagent (R3) T3 40 0 294 0 R3

Reagent (R4) T4 0 0 294 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name Direct Bili





Repeat Limit 0 10


(Male) Y A Cancel A

Y A (1) 0

0.0 0.2 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 7 7

Diluent S.Vol 0 0

Diluent Volume 0 0


BILIRUBIN AUTO DIRECT FS

Order information

Cat. No. 1 0821 .. .. …

Notes


Bilirubin Auto Direct FS for detailed information about the test on the following:






3. Manufactured by






845 0811 10 02 09 March 2004/4


Analysis

Test / Type TBIL Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 273 0 R1

Reagent (R2) T2 0 0 273 0 R2

Reagent (R3) T3 40 0 273 0 R3

Reagent (R4) T4 0 0 273 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name Total Bili





Repeat Limit 0 30


(Male) Y A Cancel A

Y A (1) 0

0.1 1.2 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 4 4

Diluent S.Vol 0 0

Diluent Volume 0 0


BILIRUBIN AUTO TOTAL FS

Order information

Cat. No 1 0811 .. .. …

Notes


Bilirubin Auto Total FS for detailed information about the test on the following:






3. Manufactured by






845 1130 10 02 09 September 2009/4


Analysis

Test / Type CALC Ser/Pl

Assay / Time / Point 1 Point A 10 A 33 0 0 0

Wave (2nd






Reagent (R1) T1 200 0 902 0 R1

Reagent (R2) T2 0 0 902 0 R2

Reagent (R3) T3 0 0 902 0 R3

Reagent (R4) T4 0 0 902 0


Prozone Limit 32000 0 Higher A


Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range

Application Code # Unit mg/dl A

Report Name Calcium





Repeat Limit 0 25


(Male) Y A Cancel A

Y A (1) 0

8.6 10.3 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 2 2

Diluent S.Vol 0 0

Diluent Volume 0 0


CALCIUM AS FS

Order information

Cat. No. 1 1130 .. .. …

Notes


Calcium AS FS for detailed information about the test on the following:






3. Manufactured by






CK-MB FS*

Order information Cat. No. Kit size 10 165 021 R1 5 x 20 ml + R2 1 x 25 ml 10 165 022 R1 5 x 80 ml + R2 1 x 100 ml 10 165 023 R1 1 x 800 ml + R2 1 x 200 ml

Method Optimized UV test according to the recommendations of the DGKC (German Society of Clinical Chemistry) and IFCC (International Federation of Clinical Chemistry) for CK-NAC. The CK-MB consists of the subunits CK-M and CK-B. A specific antibody against CK-M inhibits the complete CK-MM activity (main part of the total CK activity) and the CK-M subunit of CK-MB. Only CK-B activity is measured, which is half of the CK-MB activity.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 8 °C and protected from light.

Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Loss of activity: at 2 – 8 °C after 24 h < 10 %

at 15 - 25 °C after 1 h < 10 %.

Components and concentration in the test R1 + R2 Imidazole pH 6.7 100 mmol/l Creatine Phosphate 30 mmol/l Glucose 20 mmol/l N-Acetyl Cysteine 20 mmol/l Magnesium Acetate 10 mmol/l EDTA 2 mmol/l ADP 2 mmol/l NADP 2 mmol/l AMP 5 mmol/l Diadenosine Pentaphosphate 10 µmol/l Glucose-6-phosphate Dehydrogenase > 1.5 KU/l Hexokinase > 2.5 KU/l CK-M (human) inhibiting polyclonal antibodies (sheep) inhibiting capacity > 2000 U/l

Notes 1. Hemoglobin interferes. 2. The reagents contain Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes.

Normal range (see reference 3)

The likelihood of a cardiac infarction is high under the following circumstances:

CK Women CK Men

37 °C > 167 U/l > 190 U/l

and

CK-MB 37 °C > 24 U/l

and

A CK-MB activity between 6 and 25 % of the Total CK activity

If a cardiac infarction is suspected but the above conditions are not fulfilled, a fresh infarction may have occured. The determination should then be repeated with a fresh sample after 4 hours.

References 1. Würzburg, U., et al., Klin. Wschr., 54, (1976), 357 – 360 2. Würzburg, U., et al.‚ J. Clin. Chem. Clin. Biochem., 15,

(1977), 131 3. Stein, W., Med. Welt., (1985), 572 - 577

* fluid stable


Analysis

Test / Type CKMB Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 # 60 R1

Reagent (R2) T2 0 0 # 0 R2

Reagent (R3) T3 40 0 # 60 R3

Reagent (R4) T4 0 0 # 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range

Application Code # Unit U/l A

Report Name CK-MB





Repeat Limit 0 1000


(Male) Y A Cancel A

Y A (1) 0

0 24 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 8 8

Diluent S.Vol 0 0

Diluent Volume 0 0


11.02.11

845 1601 10 02 09 July 2009/7


Analysis

Test / Type CK Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 057 0 R1

Reagent (R2) T2 0 0 057 0 R2

Reagent (R3) T3 40 0 057 0 R3

Reagent (R4) T4 0 0 057 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name CK-NAC





Repeat Limit 0 1100


(Male) Y A Cancel A

Y A (1) 0

# # (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 6 6

Diluent S.Vol 0 0

Diluent Volume 0 0


CK-NAC FS

Order information

Cat. No. 1 1601 .. .. …

Notes


CK-NAC FS for detailed information about the test on the following:






3. Manufactured by






845 1200 10 02 09 September 2009/5


Analysis

Test / Type CL Ser/Pl

Assay / Time / Point 1 Point A 10 A 33 0 0

Wave (2nd






Reagent (R1) T1 200 0 903 0 R1

Reagent (R2) T2 0 0 903 0 R2

Reagent (R3) T3 0 0 903 0 R3

Reagent (R4) T4 0 0 903 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range

Application Code # Unit Mmol/l A

Report Name Chloride





Repeat Limit 0 130


(Male) Y A Cancel A

Y A (1) 0

98 110 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 2 2

Diluent S.Vol 0 0

Diluent Volume 0 0


CHLORIDE FS

Order information

Cat. No. 1 1200 .. .. …

Notes


Chloride FS for detailed information about the test on the following:




2. The stability of the reagent on board the analyser is 7 days

provided that contamination and evaporation are avoided.

3. Manufactured by






845 1300 10 02 09 August 2008/4


Analysis

Test / Type CHOL Ser/Pl


Wave (2nd






Reagent (R1) T1 180 0 433 0 R1

Reagent (R2) T2 0 0 433 0 R2

Reagent (R3) T3 0 0 433 0 R3

Reagent (R4) T4 0 0 433 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name Cholesterol





Repeat Limit 0 750


(Male) Y A Cancel A

Y A (1) 0

0 200 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 2 2

Diluent S.Vol 0 0

Diluent Volume 0 0


CHOLESTEROL FS

Order information Cat. No. 1 1300 .. .. …

Notes


Cholesterol FS for detailed information about the test on the following:






3. Manufactured by


**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.

845 1401 10 02 09 December 2006/7


Analysis

Test / Type CHE Ser/Pl


Wave (2nd

/Primary) 0 A 415 A





Reagent (R1) T1 160 0 434 0 R1

Reagent (R2) T2 0 0 434 0 R2

Reagent (R3) T3 40 0 434 0 R3

Reagent (R4) T4 0 0 434 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name CHE





Repeat Limit 0 20000


(Male) Y A Cancel A

Y A (1) 0

3930 10800 (2) 0

(Female) Y A (3) 0

Y A (4) 0

4620 11500 (5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 3 3

Diluent S.Vol 0 0

Diluent Volume 0 0


CHOLINESTERASE FS

Order information

Cat. No. 1 1401 .. .. …

Notes


Cholinesterase FS for detailed information about the test on the following:






3. Manufactured by






845 1711 10 02 09 March 2008/6


Analysis

Test / Type CREAT Ser/Pl

Assay / Time / Point 2 Point Rate A 10 A 19 25 0 0

Wave (2nd






Reagent (R1) T1 160 0 420 0 R1

Reagent (R2) T2 0 0 420 0 R2

Reagent (R3) T3 40 0 420 0 R3

Reagent (R4) T4 0 0 420 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name Creatinine




Technical Limit 0.0 15.0

Repeat Limit 0.0 15.0


(Male) 100 Y A Cancel A

Y A (1) 0

0.6 1.1 (2) 0

(Female) 100 Y A (3) 0

Y A (4) 0

0.5 0.9 (5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 12 12

Diluent S.Vol 0 0

Diluent Volume 0 0


CREATININE FS Order information Cat. No. 1 1711 .. .. …

Notes

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





2. The stability of the reagent on board the analyser is 4 days

provided that contamination and evaporation are avoided.

3. Manufactured by


**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.

845 1711 10 02 09 March 2008/6

HITACHI 917 Chemistry parameters – Compensated Method

Analysis

Test / Type CREAT Ser/Pl

Assay / Time / Point 2 Point Rate A 10 A 19 25 0 0

Wave (2nd






Reagent (R1) T1 160 0 420 0 R1

Reagent (R2) T2 0 0 420 0 R2

Reagent (R3) T3 40 0 420 0 R3

Reagent (R4) T4 0 0 420 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name Creatinine



Instrument Factor (Y=aX+b) a= 1.0 b= -0.3





Y A (1) 0

0.6 1.1 (2) 0

(Female) 100 Y A (3) 0

Y A (4) 0

0.5 0.9 (5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 12 12

Diluent S.Vol 0 0

Diluent Volume 0 0


CREATININE FS

Compensated Method To use the Creatinine FS Compensated Method on the Hitachi 917 the same Hitachi 917 bar sheet is utilised however 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

Note: Ensure that when using the Creatinine Compensated Method the relevant assigned Calibrator value is selected

845 1759 10 02 09 April 2011/4

HITACHI 917/MODULAR P Chemistry parameters

Analysis Test/Type Crea PAP Ser/Pl Assay/Time/Point 2 Point End A 10 A 15 33 0 0 Wave (2nd/Primary) 700 A 546 A S. Vol (Normal) 4 0 0 S. Vol (Decrease) 2 0 0 S. Vol (Increase) 12 0 0 Diluent 00951 99 Timing Reagent (R1) T1 160 0 652 0 R1 Reagent (R2) T2 0 0 652 0 R2 Reagent (R3) T3 80 0 652 0 R3 Reagent (R4) T4 0 0 652 0 Abs. Limit 0 Increase A Prozone Limit 32000 0 Upper A Cell Detergent Detergent 1 A

Calibration

Calibration type Linear A A Point 2 Span Point 2 Weight 0 Autocalibration

Time Out Change Over Blank Blank A Span Blank A 2Point Full SD Limit 0.1 Duplicate limit 10 % 200 Abs Sensitivity limit -99999 999999 S1 Abs limit -32000 32000

Range

Application Code 652 Unit mg/dl A Report Name Crea PAP Data Mode On Board A Control Interval 1000 Instrument Factor (Y=aX+b) a= 1.0 b= 0.0 Technical Limit 0 160 Repeat Limit 0 160 Expected Value Qualitative (Male) Y A Cancel A Y A (1) 0 # # (2) 0 (Female) Y A (3) 0 Y A (4) 0 # # (5) 0 (Default) Male A Range3 A (6) 0

Others <Standard> (1) (2) (3) (4) (5) (6) Calib. Code # # Concentration 0,00 * Position Sample Volume 4 4 Diluent S. Vol 0 0 Diluent Volume 0 0


CREATININE PAP FS

Order information Cat. No. 1 1759 .. .. … Notes 1. Please refer to the package insert for Creatinine PAP FS for





2. The stability of the reagent on board the analyzer is at least one

month provided that contamination and evaporation are avoided.

3. Manufactured by


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 manuf acturer or by other persons.

845 7059 10 02 09 November 2006/6


Analysis

Test / Type FERR Ser/Pl


Wave (2nd






Reagent (R1) T1 140 0 164 0 R1

Reagent (R2) T2 0 0 164 0 R2

Reagent (R3) T3 70 0 164 0 R3

Reagent (R4) T4 0 0 164 0




Calibration

Calibration type Spline A A


Weight 0


Blank Lot A

Span Bottle A

2Point

Full

SD Limit 999



S1 Abs limit -32000 32000

Range

Application Code 164 Unit µg/l A

Report Name Ferritin





Repeat Limit 0 1000


(Male) Y A Cancel A

Y A (1) 0

30 300 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 # # # #

Concentration 0.0 * * * * Position

Sample Volume 7 7 7 7 7 0

Diluent S.Vol 0 0 0 0 0 0

Diluent Volume 0 0 0 0 0 0


FERRITIN FS

Order information

Cat. No. 1 7059 .. .. …

Notes

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

information about the test on the following

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

2. The stability of the reagent on board the analyser is at least one


3. Manufactured by






845 1911 10 02 09 November 2006/5


Analysis

Test / Type IRON Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 661 0 R1

Reagent (R2) T2 0 0 661 0 R2

Reagent (R3) T3 40 0 661 0 R3

Reagent (R4) T4 0 0 661 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range

Application Code 661 Unit µg/dl A

Report Name Iron





Repeat Limit 5 1000


(Male) Y A Cancel A

Y A (1) 0

35 155 (2) 0

(Female) Y A (3) 0

Y A (4) 0

23 165 (5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 10 10

Diluent S.Vol 0 0

Diluent Volume 0 0


IRON FS Ferene

Order information

Cat. No. 1 1911 .. .. …

Notes


Iron FS Ferene for detailed information about the test on the following:






3. Manufactured by






845 0441 10 02 09 July 2009/6


Analysis

Test / Type ALP Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 158 0 R1

Reagent (R2) T2 0 0 158 0 R2

Reagent (R3) T3 40 0 158 0 R3

Reagent (R4) T4 0 0 158 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name Alk. Phos





Repeat Limit 0 1400


(Male) Y A Cancel A

Y A (1) 0

53 128 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 3 3

Diluent S.Vol 0 0

Diluent Volume 0 0


ALKALINE PHOSPHATASE FS

IFCC 37° C

Order information

Cat. No. 1 0441 .. .. …

Notes


Alkaline phosphatase FS IFCC for detailed information about the test on the following:





days provided that contamination and evaporation are avoided.

3. Manufactured by






845 2801 10 02 09 July 2009/5


Analysis

Test / Type GGT Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 479 0 R1

Reagent (R2) T2 0 0 479 0 R2

Reagent (R3) T3 40 0 479 0 R3

Reagent (R4) T4 0 0 479 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name GGT





Repeat Limit 0 1200


(Male) Y A Cancel A

Y A (1) 0

10 50 (2) 0

(Female) Y A (3) 0

Y A (4) 0

7 32 (5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 6 6

Diluent S.Vol 0 0

Diluent Volume 0 0


GAMMA-GT FS

(Szasz mod. / IFCC stand.)

Order information

Cat. No. 1 2801 .. .. …

Notes

1. Please refer to the package insert for Gamma-GT FS (Szasz

mod/IFCC stand) for detailed information about the test on the following:






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





845 2500 10 02 09 March 2004/2


Analysis

Test / Type GLUC Ser/Pl


Wave (2nd






Reagent (R1) T1 180 0 525 0 R1

Reagent (R2) T2 0 0 525 0 R2

Reagent (R3) T3 0 0 525 0 R3

Reagent (R4) T4 0 0 525 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name Glucose





Repeat Limit 0 400


(Male) Y A Cancel A

Y A (1) 0

70 115 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 2 2

Diluent S.Vol 0 0

Diluent Volume 0 0


GLUCOSE GOD FS

Order information

Cat. No. 1 2500 .. .. …

Notes


Glucose GOD FS for detailed information about the test on the following:






3. Manufactured by






845 3329 10 02 09 January 2009/5


Analysis

Test / Type HbA1c Ser/Pl


Wave (2nd

/Primary) A 660 A

S.Vol (Normal) 3.0 0 0

S.Vol (Decrease) 3.0 0 0

S.Vol (Increase) 3.0 0 0


Reagent (R1) T1 120 0 027 0 R1

Reagent (R2) T2 40 0 027 0 R2

Reagent (R3) T3 20 0 027 0 R3

Reagent (R4) T4 0 0 027 0



Cell Detergent Detergent 1,2 A

Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 999



S1 Abs limit -32000 32000

Range

Application Code 027 Unit # A

Report Name HbA1c




Technical Limit # #

Repeat Limit # #


(Male) Y A Cancel A

Y A (1) 0

# # (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 # # # #

Concentration 0.0 * * * * Position

Sample Volume 3.0 3.0 3.0 3.0 3.0

Diluent S.Vol 0 0 0 0 0

Diluent Volume 0 0 0 0 0


one HbA1c FS

Order information

Cat. No. 1 3329 .. .. …

Notes

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






8 weeks provided that contamination and evaporation are avoided.

3. Manufactured by


NOTE: For optimal performance, cuvette washes are

recommended after this assay. Use Maintenance/Utility

screen to add a cell wash using the R1 probe and the

Wash 3 position (1D3). Also use the Cell wash solution

(NaOH)





845 3521 10 02 09 March 2004/3


Analysis

Test / Type HDL Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 035 0 R1

Reagent (R2) T2 0 0 035 0 R2

Reagent (R3) T3 40 0 035 0 R3

Reagent (R4) T4 0 0 035 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name HDL C





Repeat Limit 0 180


(Male) Y A Cancel A

Y A (1) 0

35 80 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 2 2

Diluent S.Vol 0 0

Diluent Volume 0 0


HDL-C IMMUNO FS

Order information

Cat. No. 1 3521 .. .. …

Notes


HDL-C Immuno FS for detailed information about the test on the following:






3. Manufactured by






845 7239 10 02 09 September 2009/5

HITACHI 917/MODULAR P Chemistry parameters

Analysis

Test/Type IGE Ser/Pl

Assay/Time/Point 2 Point End A 10 A 18 28 0 0

Wave (2nd/Primary) 800 A 570 A

S. Vol (Normal) 3.5 0 0

S. Vol (Decrease) 2.0 0 0

S. Vol (Increase) 3.5 0 0


Reagent (R1) T1 140 0 432 0 R1

Reagent (R2) T2 0 0 432 0 R2

Reagent (R3) T3 70 0 432 0 R3

Reagent (R4) T4 0 0 432 0




Calibration



Weight 0


Blank 0 Blank A

Span 0 Blank A

2Point 0

Full 0

SD Limit 999.9



S1 Abs limit -32000 32000

Range

Application Code 453 Unit IU/ml A

Report Name IgE







(Male) Y A Cancel A

Y A (1) 0

# # (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 # # # # #

Concentration 0 * * * * * Position

Sample Volume 3.5 3.5 3.5 3.5 3.5 3.5

Diluent S. Vol 0 0 0 0 0 0



IMMUNOGLOBULIN E FS

Order information

Cat. No. 1 7239 .. .. …

Notes

1. Please refer to the package insert for Immunoglobulin E FS

for detailed information about the test on the following:




2. The stability of the reagent on board the analyzer is at least


3. Manufactured by


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.

845 4001 10 02 09 November 2006/4


Analysis

Test / Type LAC Ser/Pl


Wave (2nd






Reagent (R1) T1 240 0 040 0 R1

Reagent (R2) T2 0 0 040 0 R2

Reagent (R3) T3 60 0 040 0 R3

Reagent (R4) T4 0 0 040 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name Lactate





Repeat Limit 1 120


(Male) Y A Cancel A

Y A (1) 0

# # (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #

Concentration 0 4.0 Position

Sample Volume 4 4

Diluent S.Vol 0 0

Diluent Volume 0 0


LACTATE FS

Order information

Cat. No. 1 4001 .. .. …

Notes

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







3. Manufactured by






845 4201 10 02 09 October 2009/4


Analysis

Test / Type LDH Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 672 0 R1

Reagent (R2) T2 0 0 672 0 R2

Reagent (R3) T3 40 0 672 0 R3

Reagent (R4) T4 0 0 672 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name LDH





Repeat Limit 0 1200



16 Y A (1) 0

225 480 (2) 0

(Female) 1 Y A (3) 0

16 Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 6 6

Diluent S.Vol 0 0

Diluent Volume 0 0


LDH FS DGKC

Order information

Cat. No. 1 4201 .. .. …

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







3. Manufactured by






845 4121 10 02 09 March 2004/3


Analysis

Test / Type LDL Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 059 0 R1

Reagent (R2) T2 0 0 059 0 R2

Reagent (R3) T3 40 0 059 0 R3

Reagent (R4) T4 0 0 059 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name LDL C





Repeat Limit 0 400


(Male) Y A Cancel A

Y A (1) 0

0 130 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 2 2

Diluent S.Vol 0 0

Diluent Volume 0 0


LDL-C SELECT FS

Order information

Cat. No. 1 4121 .. .. …

Notes


LDL-C Select FS for detailed information about the test on the following:






3. Manufactured by






845 4321 10 02 09 July 2008/6


Analysis

Test / Type LIP Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 731 0 R1

Reagent (R2) T2 0 0 731 0 R2

Reagent (R3) T3 40 0 731 0 R3

Reagent (R4) T4 0 0 731 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name Lipase





Repeat Limit 0 300


(Male) Y A Cancel A

Y A (1) 0

0 60 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 4 4

Diluent S.Vol 0 0

Diluent Volume 0 0


LIPASE DC FS

Order information

Cat. No. 1 4321 .. .. …

Notes


Lipase DC FS for detailed information about the test on the following:






3. Manufactured by






845 7139 10 02 09 September 2009/5


Analysis

Test / Type LPA Ser/Pl


Wave (2nd

/Primary) A 700 A





Reagent (R1) T1 120 0 242 0 R1

Reagent (R2) T2 0 0 242 0 R2

Reagent (R3) T3 60 0 242 0 R3

Reagent (R4) T4 0 0 242 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 50.0



S1 Abs limit -32000 32000

Range

Application Code 242 Unit # A

Report Name Lpa





Repeat Limit 3 130


(Male) Y A Cancel A

Y A (1) 0

0.0 30 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 # # # # #

Concentration 0.0 * * * * * Position


Diluent S.Vol 0 0 0 0 0 0



Lp(a) 21 FS

Order information

Cat. No. 1 7139 .. .. …

Notes


Lp (a) 21 FS for detailed information about the test on the following:






3. Manufactured by






845 4610 10 02 09

November 2006/5


Analysis

Test / Type MAG Ser/Pl


Wave (2nd






Reagent (R1) T1 200 0 693 0 R1

Reagent (R2) T2 0 0 693 0 R2

Reagent (R3) T3 0 0 693 0 R3

Reagent (R4) T4 0 0 693 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name Magnesium







(Male) Y A Cancel A

Y A (1) 0

1.8 2.6 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 2 2

Diluent S.Vol 0 0

Diluent Volume 0 0


MAGNESIUM XL FS

Order information

Cat. No. 1 4610 .. .. …

Notes


Magnesium XL FS for detailed information about the test on the following:






3. Manufactured by






845 7045 10 42 09

September 2006/5

HITACHI 917 Chemistry Parameters

Analysis

Test / Type CRP Ser/Pl


Wave (2nd






Reagent (R1) T1 90 0 902 0 R1

Reagent (R2) T2 0 0 902 0 R2

Reagent (R3) T3 90 0 902 0 R3

Reagent (R4) T4 0 0 902 0




Calibration



Weight 0


Blank Lot A

Span Bottle A

2Point

Full

SD Limit 999



S1 Abs limit -32000 32000

Range

Application Code # Unit mg/l A

Report Name CRP







(Male) Y A Cancel A

Y A (1) 0

# # (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 # # # # #


Sample Volume 12 12 12 12 12 12

Diluent S.Vol 0 0

Diluent Volume 0 0


CRP U-hs High sensitive (hs) application

Order information

Cat. No. 1 7045 .. .. …

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

information about the test on the following:






3. Manufactured by

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





845 7045 10 32 09

August 2008/8


Analysis

Test / Type CRP Ser/Pl


Wave (2nd






Reagent (R1) T1 90 0 218 0 R1

Reagent (R2) T2 0 0 218 0 R2

Reagent (R3) T3 90 0 218 0 R3

Reagent (R4) T4 0 0 218 0




Calibration



Weight 0


Blank Lot A

Span Bottle A

2Point

Full

SD Limit 999



S1 Abs limit -32000 32000

Range

Application Code 218 Unit mg/l A

Report Name CRP







(Male) Y A Cancel A

Y A (1) 0

# # (2) 0

(Female) Y A (3) 0

Y A (4) 0

# # (5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 # # # # #



Diluent S.Vol 0 0

Diluent Volume 0 0


CRP U-hs Universal (U) application

Order information

Cat. No. 1 7045 .. .. …

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







3. Manufactured by

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





845 2311 10 02 09

November 2006/5


Analysis

Test / Type TP Ser/Pl


Wave (2nd

/Primary) 0 A 546 A





Reagent (R1) T1 160 0 678 0 R1

Reagent (R2) T2 0 0 678 0 R2

Reagent (R3) T3 40 0 678 0 R3

Reagent (R4) T4 0 0 678 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range

Application Code 678 Unit g/dl A

Report Name Total Protein







(Male) Y A Cancel A

Y A (1) 0

6.6 8.8 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 4 4

Diluent S.Vol 0 0

Diluent Volume 0 0


TOTAL PROTEIN FS

Order information

Cat. No. 1 2311 .. .. …

Notes


Total Protein FS for detailed information about the test on the following:






3. Manufactured by






845 0210 10 52 09

September 2008/5


Analysis

Test / Type TPU Ser/Pl

Assay / Time / Point 1 Point A 10 A 33 0 0 0

Wave (2nd






Reagent (R1) T1 200 0 769 0 R1

Reagent (R2) T2 0 0 769 0 R2

Reagent (R3) T3 0 0 769 0 R3

Reagent (R4) T4 0 0 769 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name TPU







(Male) Y A Cancel A

Y A (1) 0

24 141 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 4 4

Diluent S.Vol 0 0

Diluent Volume 0 0


TOTAL PROTEIN UC FS

Order information

Cat. No. 1 0210 .. .. …

Notes


Total Protein UC information about the test on the following:






3. Manufactured by






845 2601 10 02 09

March 2010/9


Analysis

Test / Type ASAT Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 253 0 R1

Reagent (R2) T2 0 0 253 0 R2

Reagent (R3) T3 40 0 253 0 R3

Reagent (R4) T4 0 0 253 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range

Application Code ## Unit U/l A

Report Name ASAT





Repeat Limit 0 700



Y A 0 37 (1) 0

0 37 (2) 0

(Female) 100 Y A 0 31 (3) 0

Y A 0 31 (4) 0

0 31 (5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #

Concentration 0 *

Position

Sample Volume 12 12

Diluent S.Vol 0 0

Diluent Volume 0 0


##) Enter relevant application code 457 without PYP and application code 143 with PYP

ASAT(GOT) FS (IFCC mod.)

Order information

Cat. No. 1 2601 .. .. …

Notes


ASAT(GOT) FS (IFCC Mod) for detailed information about the test on the following:






3. Manufactured by


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.





845 2701 10 02 09

July 2009/5


Analysis

Test / Type ALAT Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 106 0 R1

Reagent (R2) T2 0 0 106 0 R2

Reagent (R3) T3 40 0 106 0 R3

Reagent (R4) T4 0 0 106 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range

Application Code ## Unit U/l A

Report Name ALAT





Repeat Limit 0 600



Y A 0 42 (1) 0

0 42 (2) 0

(Female) 100 Y A 0 32 (3) 0

Y A 0 32 (4) 0

0 32 (5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 12 12

Diluent S.Vol 0 0

Diluent Volume 0 0

#) Data entry by the user *) Enter calibration or standard value ##) Enter relevant application code 075 without PYP and application code

098 with PYP

ALAT(GPT) FS (IFCC mod.)

Order information

Cat. No. 1 2701 .. .. …

Notes

1. Please refer to the package insert for ALAT(GPT) FS (IFCC

Mod.) for detailed information about the test on the following:






3. Manufactured by






845 5710 10 02 09 March 2004/3


Analysis

Test / Type TRIG Ser/Pl


Wave (2nd






Reagent (R1) T1 180 0 781 0 R1

Reagent (R2) T2 0 0 781 0 R2

Reagent (R3) T3 0 0 781 0 R3

Reagent (R4) T4 0 0 781 0




Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range


Report Name Triglycerides





Repeat Limit 0 1000


(Male) Y A Cancel A

Y A (1) 0

0 200 (2) 0

(Female) Y A (3) 0

Y A (4) 0

(5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 2 2

Diluent S.Vol 0 0

Diluent Volume 0 0


TRIGLYCERIDES FS

Order information

Cat. No. 1 5710 .. .. …

Notes


Triglycerides FS for detailed information about the test on the following:






3. Manufactured by






845 3101 10 02 09 November 2006/7


Analysis

Test / Type UREA Ser/Pl


Wave (2nd






Reagent (R1) T1 160 0 418 0 R1

Reagent (R2) T2 0 0 418 0 R2

Reagent (R3) T3 40 0 418 0 R3

Reagent (R4) T4 0 0 418 0


Prozone Limit 32000 0 higher A


Calibration



Weight 0


Blank Blank A

Span Blank A

2Point

Full

SD Limit 0.1



S1 Abs limit -32000 32000

Range

Application Code 418 Unit Mg/dl A

Report Name Urea





Repeat Limit 2 300



Y A 0 0 (1) 0

17 43 (2) 0

(Female) 100 Y A 0 0 (3) 0

Y A 0 0 (4) 0

0 0 (5) 0


Others

<Standard> (1) (2) (3) (4) (5) (6)

Calib. Code 501 #


Sample Volume 2 2

Diluent S.Vol 0 0

Diluent Volume 0 0


UREA FS

Order information

Cat. No. 1 3101 .. .. …

Notes

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







3. Manufactured by






HITACHI 917 ALBUMIN FS - AsteriscoHITACHI 917 ALBUMIN FS Chemistry parameters Analysis Test / Type...

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