Hitachi 902 instructions - Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902...
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Chema Diagnostica Via Campania 2/4 I-60030 Monsano | An Italy T +39 0731 605064 | F +39 0731 605672 www.chema.com | [email protected] Hitachi 902 instructions rev 416.0.2 - 2010-08-01
Transcript of Hitachi 902 instructions - Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902...
Chema DiagnosticaVia Campania 2/4I-60030 Monsano | An ItalyT +39 0731 605064 | F +39 0731 605672www.chema.com | [email protected]
Hitachi 902 instructionsrev 416.0.2 - 2010-08-01
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 3 of 40
Warning!
These programs should be used only as guideline.
To check the reagent correct setting on the
instrument, use only good quality control sera
and work accordingly to with good laboratory
practice. Instrumental factor must be checked.
Chema Diagnostica will not be responsible for
instrumental bad programming.
Hitachi 902 instructionsrev 416.0.2 - 2010-08-01
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 4 of 40
Application: ACIDPHOSPHATASE- Codes AC 0120 TC Preparation: POWDER SINGLE REAGENT. FOLLOW PREPARATION PROGRAM INDICATED IN INSERT SHEET. INSTALL AS R1 Storage: REFRIGERATE AT 2-8°C
1 Test Name ACP2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 196 Assay Point 2 337 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 41511 Sample Volume 30.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 5 of 40
Application: ALBUMIN- Codes BC 0100 / 0500 / 1000 / 1500 CH Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT Storage: REFRIGERATE (2-8°C) Stability: AS INDICATED IN THE LABEL
1 Test Name ALB2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 60011 Sample Volume 3.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 6 of 40
Application: ALKALINEPHOSPHATASEDGKCFL - Codes AL F080 / F245 / F400 / F600 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name ALP2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 206 Assay Point 2 267 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 41511 Sample Volume 6.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 7 of 40
Application: ALKALINEPHOSPHATASEIFCCFL - Codes AF F080 / F245 / F400 / F600 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name ALP2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 206 Assay Point 2 267 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 41511 Sample Volume 6.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 8 of 40
Application: AMYLASEFL - Codes AM F060 / F120 / F245 CH Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name AMY2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 76 Assay Point 2 147 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 41511 Sample Volume 10.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 9 of 40
Application: AMYLASEEPSFL - Code EA F080 / F245 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name AMY2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 246 Assay Point 2 307 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 41511 Sample Volume 12.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 10 of 40
Application: PANCREATICISOAMYLASEFL - Code PA F080 / F245 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name IAMY2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 246 Assay Point 2 307 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 41511 Sample Volume 12.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 11 of 40
Application: BICARBONATEFL- Codes BR F060 / F245 / F400 CH Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT Storage: REFRIGERATE (2-8°C) Stability: AS INDICATED IN THE LABEL
1 Test Name CO22 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 206 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 41511 Sample Volume 3.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Decrease51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 5054 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 12 of 40
Application: BILIRUBINTOTALFL- Code DT F125 / F500 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name BT2 Assay Code (Mthd) 2 Point End3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 176 Assay Point 2 357 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 50511 Sample Volume 15.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 3200052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 13 of 40
Application: BILIRUBINDIRECTFL- Code DD F125 / F500 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name BD2 Assay Code (Mthd) 2 Point End3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 176 Assay Point 2 357 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 54611 Sample Volume 15.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 3200052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 14 of 40
Application: CALCIUM - Code CA 0305 / 0505 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT B R2 - INSTALL LIQUID READY TO USE REAGENT A Storage: ROOM TEMPERATURE OR REFRIGERATE (2-30°C) Stability: AS INDICATED IN THE LABEL
1 Test Name CA2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 54611 Sample Volume 5.012 R1 Volume 15013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 15016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 15 of 40
Application: CALCIUMASX - Code CA 0100 / 0500 CH Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT Storage: ROOM TEMPERATURE OR REFRIGERATE (2-30°C) Stability: AS INDICATED IN THE LABEL
1 Test Name CA2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 66011 Sample Volume 3.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 16 of 40
Application: CHOLESTEROLFL - Codes CT F100 / F400 / 100F / 150F CH Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name CHOL2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 50511 Sample Volume 3.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 17 of 40
Application: HDLdirectFL- Code HD F080 / F245 / F400 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B CALIBRATOR - RECONSTITUTE AS INDICATED IN INSERT SHEET Storage: REFRIGERATE AT 2-8°C Stability: 60 DAYS OPEN BOTTLES - CALIBRATOR: AS INDICATED IN INSERT SHEET
1 Test Name HDL2 Assay Code (Mthd) 2 Point End3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 176 Assay Point 2 357 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 60011 Sample Volume 4.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 10016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 18 of 40
Application: LDLdirectFL- Code DL F080 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B CALIBRATOR - RECONSTITUTE AS INDICATED IN INSERT SHEET Storage: REFRIGERATE AT 2-8°C Stability: 60 DAYS OPEN BOTTLES - CALIBRATOR: AS INDICATED IN INSERT SHEET
1 Test Name LDL2 Assay Code (Mthd) 2 Point End3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 176 Assay Point 2 357 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 60011 Sample Volume 4.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 10016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 19 of 40
Application: CHOLINESTERASEFL(DGKC)- Codes CH F096 / F245 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name CHE2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 206 Assay Point 2 287 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 41511 Sample Volume 4.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Decrease51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 20 of 40
Application: CK-NACFL - Codes CK F060 / F120 / F245 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name CK2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 246 Assay Point 2 327 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 66010 Wavelenght (MAIN) 34011 Sample Volume 10.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 21 of 40
Application: CK-MBFL - Codes MB F060 / F120 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name CKMB2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 246 Assay Point 2 327 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 66010 Wavelenght (MAIN) 34011 Sample Volume 10.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 22 of 40
Application: COPPER- Code CU 0100 CH Preparation: R1 - MIX REAGENT A + REAGENT B AS INDICATED IN INSERT SHEET Storage: ROOM TEMPERATURE (AVOID REFRIGERATION!) Stability: 2 WEEKS
1 Test Name CU2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 60011 Sample Volume 20.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 23 of 40
Application: CREATININE- Code CR 0500 / 1000 / 1500 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT B R2 - INSTALL LIQUID READY TO USE REAGENT A Storage: ROOM TEMPERATURE OR REFRIGERATE (2-30°C) Stability: AS INDICATED IN THE LABEL
1 Test Name CREA2 Assay Code (Mthd) 2 Point Kin3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 206 Assay Point 2 237 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 50511 Sample Volume 20.012 R1 Volume 15013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 15016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 24 of 40
Application: GAMMA-GTFL - Codes GT F080 / F245 / F400 / F600 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name GGT2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 206 Assay Point 2 287 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 41511 Sample Volume 15.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 25 of 40
Application: GLUCOSEFL - Codes GL F100 / F400 / 100F / 150F CH Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name GLUC2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 50511 Sample Volume 3.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 26 of 40
Application: GLUCOSEUVFL - Code GL F601 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name GLUC2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 34011 Sample Volume 3.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size ***18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 27 of 40
Application: GOT/ASTFL - Codes GO F080 / F245 / F400 / F600 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name GOT2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 226 Assay Point 2 307 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 66010 Wavelenght (MAIN) 34011 Sample Volume 20.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Decrease51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 28 of 40
Application: GPT/ALTFL - Codes GP F080 / F245 / F400 / F600 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name GPT2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 226 Assay Point 2 307 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 66010 Wavelenght (MAIN) 34011 Sample Volume 20.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Decrease51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 29 of 40
Application: IRONFZ - Codes FE F245 / F400 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B (preparation: read insert sheet) Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name FE2 Assay Code (Mthd) 2 Point End3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 176 Assay Point 2 357 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 57011 Sample Volume 40.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 30 of 40
Application: LDHFL - Codes LD F060 / F120 / F245 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name LDH2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 206 Assay Point 2 267 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 66010 Wavelenght (MAIN) 34011 Sample Volume 3.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Decrease51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 31 of 40
Application: LIPASEFL - Codes LP F060 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name LIP2 Assay Code (Mthd) Rate A3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 206 Assay Point 2 267 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 57011 Sample Volume 5.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 10046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Decrease51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 32 of 40
Application: MAGNESIUM- Codes MG 0200 / 0500 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT B R2 - INSTALL LIQUID READY TO USE REAGENT A Storage: ROOM TEMPERATURE OR REFRIGERATE (2-30°C) Stability: AS INDICATED IN THE LABEL
1 Test Name MG2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 50511 Sample Volume 3.012 R1 Volume 15013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 15016 R2 Pos. ***17 R2 Bottle Size ***18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 33 of 40
Application: MAGNESIUMXL- Codes MX 0300 / 0500 CH Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name MG2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 50511 Sample Volume 3.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. ***17 R2 Bottle Size ***18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 34 of 40
Application: PHOSPHORUS- Code PH 0100 / 0500 CH Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN INSERT SHEET
1 Test Name PHOS2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 34011 Sample Volume 3.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 35 of 40
Application: PROTEINSHS- Code HS 0100 / 0500 CH Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT Storage: ROOM TEMPERATURE OR REFRIGERATE (2-30°C) Stability: AS INDICATED IN THE LABEL
1 Test Name HS2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 60011 Sample Volume 3.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 36 of 40
Application: TOTALPROTEINS- Codes TP 0100 / 0500 / 1000 / 1500 CH Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name TP2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 54611 Sample Volume 3.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 37 of 40
Application: TRIGLYCERIDESFL - Code TR F100 / F400 / 100F / 150F CH Preparation: R1 - LIQUID READY TO USE SINGLE RAGENT Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name TRIG2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 50511 Sample Volume 3.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 38 of 40
Application: UREAUVFL - Codes AZ F080 / F245 / F400 / F600 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name UREA2 Assay Code (Mthd) 2 Point Kin3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 206 Assay Point 2 237 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 66010 Wavelenght (MAIN) 34011 Sample Volume 3.012 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 650050 Abs. Limit (D/I) Decrease51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 39 of 40
Application: URICACIDTFL - Code AU F402 CH Preparation: R1 - MIX REAGENT A + REAGENT B AS INDICATED IN INSERT SHEET Storage: REFRIGERATE AT 2-8°C Stability: 90 DAYS
1 Test Name UA2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 54611 Sample Volume 10.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 40 of 40
Application: URICACIDAOXFL - Code AX F125/F250/F600 CH Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A R2 - INSTALL LIQUID READY TO USE REAGENT B Storage: REFRIGERATE AT 2-8°C Stability: AS INDICATED IN THE LABEL
1 Test Name AU2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 54611 Sample Volume 1512 R1 Volume 24013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 6016 R2 Pos. ***17 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
Analyzer: Hitachi902
Chema Diagnostica - Guidelines for automatic analyzers - Hitachi 902
IUS.416.0.2 Directions for use Edition 2010-08-01 page 41 of 40
Application: ZINC - Code ZN 0125 CH Preparation: R1 - MIX REAGENT A + REAGENT B AS INDICATED IN INSERT SHEET Storage: REFRIGERATE AT 2-8°C Stability: 2 WEEKS
1 Test Name ZN2 Assay Code (Mthd) 1 Point3 Assay Code (2. Test) 04 Reaction Time 105 Assay Point 1 356 Assay Point 2 07 Assay Point 3 08 Assay Point 4 09 Wavelenght (SUB) 70010 Wavelenght (MAIN) 60011 Sample Volume 20.012 R1 Volume 30013 R1 Pos. ***14 R1 Bottle Size ***15 R2 Volume 016 R2 Pos. 017 R2 Bottle Size Small18 R3 Volume 019 R3 Pos. 020 R3 Bottle Size Small21 Calib. Type (Type) Linear22 Calib. Type (Wght) 023 Calib. Conc. 1 024 Calib. Pos. 1 ***25 Calib. Conc. 2 ***26 Calib. Pos. 2 ***27 Calib. Conc. 3 028 Calib. Pos. 3 029 Calib. Conc. 4 030 Calib. Pos. 4 031 Calib. Conc. 5 032 Calib. Pos. 5 033 Calib. Conc. 6 034 Calib. Pos. 6 0
35 S1 ABS 036 K Factor 1000037 K2 Factor 1000038 K3 Factor 1000039 K4 Factor 1000040 K5 Factor 1000041 A Factor 042 B Factor 043 C Factor 044 SD Limit 0.145 Duplicate Limit 20046 Sens. Limit 047 S1 Abs. LIMIT (L) -3200048 S1 Abs. LIMIT (H) 3200049 Abs. Limit 050 Abs. Limit (D/I) Increase51 Prozone Limit 052 Proz. Limit (Upp/Low) Lower53 Prozone (End Point) 3554 Expect. Value (L) ***55 Expect. Value (H) ***56 Instr. Fact. (a) 1.057 Instr. Fact. (b) 0.058 Key Setting ***
