HbA. Reagent ID: 035 ISE. Range. General. Yes. Test Name: HbA1cΨ

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ba c, AU4/AU4 e I Reagent ID: 35 bacψ Operation: Sample: Reagents: Volume R Volume 3.5 76 μ μ Dilution Dilution μ μ R2 Volume 76 μ Dilution μ Wavelength: Pri. 7 FIXED Sec. ne + Measuring Point : Measuring 3 ast ast 22 inearity: ag Time: Pre-Dilution Rate: Min ast Dynamic : ** Correlation Factor: A On-board stability period: Max ast ** 3 I bacψ rmal s: Age evel :. 2. 3. 4. 5. 6. 7. ne Selected 8. Out of Panic Value: Age Year evel : Month Unit: g/d* Decimal places: bacψ Type Calibration 6A Formula: POYGONA Counts: Process: CONC Point : -Point Cal. Point: M Type Factor: Cal.. With CONC- CONC Factor/- Factor/- Slope Check - Advanced Calibration: Calibration Stability Period: 4 User Defined ot or ot + ottle eckman Coulter System Calibrator R332 * Values set for working in g/d ** Concentration of lowest and highest calibrators Ψ For determinationn of bac the above tests (Tb and bac) are used. A third test bac must also be entered in the general tests and the calculated tests of the test section menu ( no settings required). Set this test as CACUATED TEST in the INTER TEST menu. Enter the formula (A/*a)+b, where A= =bac, =Tb and a=9.5, b= =2.5. ASOSR6x92.4 24-8

ba c, AU64/AU64 e I Reagent ID: 35 bacψ Operation: Sample: Reagents: Volume R Volume 3.5 76 μ μ Dilution Dilution μ μ R2 Volume 76 μ Dilution μ Wavelength: Pri. 7 FIXED Sec. ne + Measuring Point : Measuring 3 ast ast 22 inearity: ag Time: Pre-Dilution Rate: Min ast Dynamic : ** Correlation Factor: A On-board stability period: Max ast ** 3 I bacψ rmal s: Age evel :. 2. 3. 4. 5. 6. 7. ne Selected 8. Out of Panic Value: Age Year evel : Month Unit: g/d* Decimal places: bacψ Type Calibration 6A Formula: POYGONA Counts: Process: CONC Point : -Point Cal. Point: M Type Factor: Cal.. With CONC- CONC Factor/- Factor/- Slope Check - Advanced Calibration: Calibration Stability Period: 4 User Defined ot or ot + ottle eckman Coulter System Calibrator R332 * Values set for working in g/d. ** Concentration of lowest and highest calibrators Ψ For determinationn of bac the above tests (Tb and bac) are used. A third test bac must also be entered in the general tests and the calculated tests of the test section menu ( no settings required). Set this test as CACUATED TEST in the INTER TEST menu. Enter the formula (A/*a)+b, where A= =bac, =Tb and a=9.5, b= =2.5. ASOSR6x92.4 24-8

ba c, AU48 I bac ж Sample Volume Pre-Dilution Rate 3 μ Dilution μ Reagents Volume: R(R-) 65 μ Dilution μ R2 (R2-) 65 μ Dilution μ Wavelength: Pri. 7 nm Sec. ne nm FIXED + Measuring Point : Measuring 3 ast ast 22 inearity: ag Time: imit Min. -. ow ast ow Dynamic ow Correlation Factor A Factor for Maker A ** ** Onboard Stability 3 Day our I Influence Check ipemia Icterus +++++ + +++++ + emolysis +++++ + Reagent ID: 35 Operation: Max. bac ж Specific s: evel : From To Year Month ow. 2. 3. 4. 5. 6. 7. demographics 8. t within expected values Unit g/d* Decimal Places evel : Panic Value ow bac ж Type Use Cal. Calibration 6A Formula: POYGONA Counts: Calibrator Parameters Slope Check - Calibrator Conc Factor ow Allowable Check Point : Reagent lank Calibration Advanced Calibration Operation Interval (R/ACA) ottle/ottle Point 8: Point 9: Point: Point Cal. For Master Curve Calibrator Point : M Type Factor:. of Correction Points Conc -Point Calibration Point Use Master Curve ot Calibration Stability ow Reagent lanks 4 Day our Calibration 4 Day our User Defined eckman Coulter System Calibrator Cat..: R332 * Values set for working in g/d. To work in mmol/ divide by.625. ** Concentration of lowest and highest calibrators. ж Set this test in Common Parameter test name in CACUATED TEST. Enter the formula (A/)*a+b, where A= =ba c, =Tb and a=9.5 and b=2.5 in Parameters CACUATED TEST ASOSR6x92.4 24-8 With CONC-

ba c, AU68 I bac ж Sample Volume Pre-Dilution Rate 3 μ Dilution μ Reagents Volume: R(R-) 65 μ Dilution μ R2 (R2-) 65 μ Dilution μ Common Reagent Type ne Name Wavelength: Pri. 7 nm Sec. ne nm FIXED + Measuring Point : Measuring 3 ast ast 22 inearity: ag Time: imit Min. -. ow ast ow Dynamic ow Correlation Factor A Factor for Maker A ** ** Onboard Stability 3 Days our I Influence Check ipemia +++++ + Icterus +++++ + emolysis +++++ + Reagent ID: 35 Operation: Max. bac ж Specific s: evel : From To Year Month ow. 2. 3. 4. 5. 6. 7. demographics 8. t within expected values Unit g/d* Decimal Places evel : Panic Value ow bac ж Type Use Cal. Calibration 6A Formula: POYGONA Counts: Calibrator Parameters Slope Check - Calibrator Conc Factor ow Allowable Check Point : Reagent lank Calibration Advanced Calibration Operation Interval (R/ACA) ottle/ottle Point 8: Point 9: Point: Point Cal. For Master Curve Calibrator Point : M Type Factor:. of Correction Points Conc -Point Calibration Point Use Master Curve ot Calibration Stability ow Reagent lanks 4 Day our Calibration 4 Day our User Defined eckman Coulter System Calibrator Cat..: R332 * Values set for working in g/d. To work in mmol/ divide by.625. ** Concentration of lowest and highest calibrators. ж Set this test in Common Parameter test name in CACUATED TEST. Enter the formula (A/)*a+b, where A= =ba c, =Tb and a=9.5 and b=2.5 in Parameters CACUATED TEST ASOSR6x92.4 24-8 With CONC-

ba c, AU6 Specific test parameters Reagent ID: 35 name bacψ Sample type Ser Page /2 Sample vol. Reagent vol Reagent 2 vol Wave Method Reaction Point Point 2 3.5 76 76 Main 7 Fst 3 Fst Dil. vol μl Min. Dil. vol μl Dil. vol μl Reagent limit Fst. Sub ne st. FIXED Dynamic range + ** st 222 Correlation factor st Max. Fst. st. A ** inearity lag time Fst Sec On-board stability period 3 Select using Space key, or select from list displayed by Guide key name bacψ Sample type Ser Page 2/2 Value/flag rmal range 2 3 4 5 6 7 8 Panic value Sex n select Out of range Age Y Y Y Y Y Y Age M Y M Y M Y M Y M Y M Y evel evel Select the function using the Function key or the Mouse Calibration specificc Name bacψ Cal type 4 6A Formula Selection calibrator 3 POYGONA Cal Point Point 2 Point 3 Point 4 Point 5 Point 6 Point 7 -point cal. point M type factor Calibrator stability period 4 Conc Count Process Factor/- Conc Factor/- Select the function using the Function key or the Mouse User Defined eckman Coulter System Calibrator R332 * Values set for working in g/d ** Concentration of lowest and highest calibrators Ψ For determination of bac the above tests (Tb and bac) are used. A third test bac must also be entered in the general tests and the calculated tests of the test section menu (no settings required). Set this test as CACUATED TEST in the INTER TEST menu. Enter the formula (A/*a)+b, where A=bAc, =Tb and a=9.5, b=2.5. ASOSR6x92.4 24-8

ba c, AU27/AU54 I Reagent ID: 35 bacψ Operation: Sample: Reagents: Volume R Volume 3 65 μ μ Dilution Dilution μ μ R2 Volume 65 μ Dilution μ Wavelength: Pri. 7 FIXED Sec. ne + Measuring Point : Measuring 3 ast ast 22 inearity: ag Time: Pre-Dilution Rate: Min -. ast Dynamic : ** Correlation Factor: A On-board stability period: Max ast ** 3 I bacψ rmal s: Age evel : Age Year. 2. 3. 4. 5. 6. 7. ne Selected 8. Out of Panic Value: Month evel : Unit: g/d* Decimal places: bacψ Type Calibration 6A Formula: POYGONA Counts: Process: CONC Point : -Point Cal. Point: M Type Factor: Cal.. With CONC- CONC Factor/- Factor/- Slope Check - Advanced Calibration: Calibration Stability Period: 4 User Defined ot or ot + ottle eckman Coulter System Calibrator R332 * Values set for working in g/d. ** Concentration of lowest and highest calibrators Ψ For determinationn of bac the above tests (Tb and bac) are used. A third test bac must also be entered in the general tests and the calculated tests of the test section menu ( no settings required). Set this test as CACUATED TEST in the INTER TEST menu. Enter the formula (A/*a)+b, where A= =bac, =Tb and a=9.5, b= =2.5. ASOSR6x92.4 24-8

bac, AU58 System Reagent: OSR6x92 Parameters I bac Calculated Reagent ID: 35 Name: bacж Operation Sample Volume Pre-Dilution Rate Rgt. Volume R(R-) 2.4 52 R-2 Common Rgt. Type Wavelength Method Reaction Slope Measuring Point st Measuring Point2 st inearity imit ag Time Check R2(R2-) 52 ne Pri 7 nm FIXED + 3 μ μ μ μ Dilution μ imit Diluent ottle Min. -. Max. Dilution μ Reagent imit Dilution μ st. ow ast ow Dilution μ Dynamic ow ** ** Name ne Correlation Factor A Sec. NONE nm Factor for Maker A ast ast Onboard Stability Period 3 Day our 22 I Influence Check ipemia +++++ Icterus +++++ emolysis +++++ Parameters I bac Calculated bacж evel ow Specific s: From To Sex Year Month Year Month ow. 2. 3. 4. 5. 6. 7. Standardd demographics 8. t within expected values Panic Value ow Unit g/d* Decimal Places Parameters Calibration Parameters Calibrators bacж Type Use Cal. Calibration 6A Formula: POYGONA Counts: Calibrator Parameters Calibrator Conc ow Slope Check - Point : Allowance Check Reagent lank Calibration Advanced Calibration Point 8: Point 9: Operation Point : Interval (R/ACA) ottle/ottle Point Cal. For. of Correction Points Use Master Curve ot Calibration Master Curve Calibratorr Conc ow Stability Point- Point-2 Reagent lank Calibration 4 4 Day Day our our M Type Factor: -Point Calibration Point ne with Conc- User defined eckman Coulter System Calibratorr R332. * Values set for working in g/d. To work in mmol/,divide by.625. ** Concentration of.6g/d and highest calibrator. ж Set this test in Common Parameter test name as CACUATED TEST. Enter the formula (A/)*a+b, where A=bA c, =Tb and a=9.5 and b=2.5 in Parameters CACUATED TEST Cuvette. ASOSR6x92.4 24-8

TOTA b, AU4/AU4 e I Reagent ID: 92 TbΨ Operation: Sample: Volume μ Dilution μ Reagents: R Volume 5 μ Dilution μ R2 Volume μ Dilution μ Wavelength: Pri. 6 Sec. 7 END + Measuring Point : Measuring ast ast 27 inearity: ag Time: Pre-Dilution Rate: Min ast Dynamic : 7.* Correlation Factor: A On-board stability period: Max ast 23.* 3 I TbΨ rmal s: Age evel :. 2. 3. 4. 5. 6. 7. ne Selected 8. Out of Panic Value: Age Year evel : Month Unit: g/d* Decimal places: TbΨ Type Calibration A Formula: Y=AX+ Counts: Process: CONC Point : -Point Cal. Point: M Type Factor: Cal.. With CONC- CONC Factor/- Factor/- -99999 99999 Slope Check ne Advanced Calibration: Calibration Stability Period: 4 User Defined ot or ot + ottle eckman Coulter System Calibrator R332 * Values set for working in g/d Ψ For determinationn of bac the above tests (Tb and bac) are used. A third test bac must also be entered in the general tests and the calculated tests of the test section menu (no settings required). Set this test as CACUATED TEST in the INTER TEST menu. Enter the formula (A/*a)+ +b, where A=bAc, =Tb and a= =9.5, b=2.5. ASOSR6x92.4 24-8

TOTA b, AU64/AU64 e I Reagent ID: 92 TbΨ Operation: Sample: Volume μ Dilution μ Reagents: R Volume 5 μ Dilution μ R2 Volume μ Dilution μ Wavelength: Pri. 6 Sec. 7 END + Measuring Point : Measuring ast ast 27 inearity: ag Time: Pre-Dilution Rate: Min ast Dynamic : 7.* Correlation Factor: A On-board stability period: Max ast 23.* 3 I TbΨ rmal s: Age evel :. 2. 3. 4. 5. 6. 7. ne Selected 8. Out of Panic Value: Age Year evel : Month Unit: g/d* Decimal places: TbΨ Type Calibration A Formula: Y=AX+ Counts: Process: CONC Point : -Point Cal. Point: M Type Factor: Cal.. With CONC- CONC Factor/- Factor/- -99999 99999 Slope Check ne Advanced Calibration: Calibration Stability Period: 4 User Defined ot or ot + ottle eckman Coulter System Calibrator R332 * Values set for working in g/d Ψ For determinationn of bac the above tests (Tb and bac) are used. A third test bac must also be entered in the general tests and the calculated tests of the test section menu (no settings required). Set this test as CACUATED TEST in the INTER TEST menu. Enter the formula (A/*a)+ +b, where A=bAc, =Tb and a= =9.5, b=2.5. ASOSR6x92.4 24-8

TOTA b, AU48 I Tb ж Sample Volume 9.5 μ Dilution μ Pre-Dilution Rate Reagents Volume: R(R-) 3 μ Dilution μ R2 (R2-) μ Dilution μ Wavelength: Pri. 6 nm Sec. 7 nm END + Measuring Point : Measuring ast ast 27 inearity: ag Time: imit Min. Max. ow ast ow Dynamic ow Correlation Factor A Factor for Maker A 7* 23* Onboard Stability 3 Day our I Influence Check ipemia +++++ + Icterus +++++ + emolysis +++++ + Reagent ID: 92 Operation: Tb ж Specific s: evel : From To Year Month ow. 2. 3. 4. 5. 6. 7. demographics 8. t within expected values Unit g/d* Decimal Places evel : Panic Value ow Tb ж Calibration Calibrator Parameters A Formula: Calibrator Conc Point : Point 8: Point 9: Point: Point Cal. For Master Curve Calibrator Point : M Type Factor:. of Correction Points Conc Y=AX+ Counts: Slope Check ne Factor ow Allowable Check -99999 99999 Reagent lank Calibration Advanced Calibration Operation Interval (R/ACA) ottle/ottle -Point Calibration Point Type Use Master Curve ot Calibration Stability ow Reagent lanks 4 Day our Calibration 4 Day our User Defined eckman Coulter System Calibrator Cat..: R332 * Values set for working in g/d. To work in mmol/ divide by.625. ж Set this test in Common Parameter test name in CACUATED TEST. Enter the formula (A/)*a+b, where A= =ba c, =Tb and a=9.5 and b=2.5 in Parameters CACUATED TEST With CONC- Use Cal. ASOSR6x92.4 24-8

TOTA b, AU68 I Tb ж Sample Volume 9.5 μ Dilution μ Pre-Dilution Rate Reagents Volume: R(R-) 3 μ Dilution μ R2 (R2-) μ Dilution μ Common Reagent Type ne Name Wavelength: Pri. 6 nm Sec. 7 nm END + Measuring Point : Measuring ast ast 27 inearity: ag Time: imit Min. ow ast ow Dynamic ow Correlation Factor A Factor for Maker A 7* 23* Onboard Stability 3 Days our I Influence Check ipemia +++++ + Icterus +++++ + emolysis +++++ + Reagent ID: 92 Operation: Max. Tb ж Specific s: evel : From To Year Month ow. 2. 3. 4. 5. 6. 7. demographics 8. t within expected values Unit g/d* Decimal Places evel : Panic Value ow Tb ж Calibration Calibrator Parameters A Formula: Calibrator Conc Point : Point 8: Point 9: Point: Point Cal. For Master Curve Calibrator Point : M Type Factor:. of Correction Points Conc Y=AX+ Counts: Slope Check ne Factor ow Allowable Check -99999 99999 Reagent lank Calibration Advanced Calibration Operation Interval (R/ACA) ottle/ottle -Point Calibration Point Type Use Master Curve ot Calibration Stability ow Reagent lanks 4 Day our Calibration 4 Day our User Defined eckman Coulter System Calibrator Cat..: R332 * Values set for working in g/d. To work in mmol/ divide by.625. ж Set this test in Common Parameter test name in CACUATED TEST. Enter the formula (A/)*a+b, where A= =ba c, =Tb and a=9.5 and b=2.5 in Parameters CACUATED TEST With CONC- Use Cal. ASOSR6x92.4 24-8

TOTA b, AU6 Specific test parameters Reagent ID: 92 name TbΨ Sample type Ser Page /2 Sample vol. Reagent vol Reagent 2 vol Wave Method Reaction Point Point 2 5 Main 6 Fst Fst Dil. vol μl Min. Dil. vol μl Dil. vol μl Reagent limit Fst. Sub 7 st. END Dynamic range + 7.* st 27 Correlation factor st Max. Fst. st. 23.* A inearity lag time Fst Sec On-board stability period 3 Select using Space key, or select from list displayed by Guide key name TbΨ Sample type Ser Page 2/2 Value/flag rmal range 2 3 4 5 6 7 8 Panic value Sex n select Out of range Age Y Y Y Y Y Y Age M Y M Y M Y M Y M Y M Y evel evel Select the function using the Function key or the Mouse Calibration specificc Name TbΨ Cal type Formula 8 Selection calibrator Cal Point Point 2 Point 3 Point 4 Point 5 Point 6 Point 7 -point cal. point M type factor Calibrator stability period A Y=AX+ 4 Conc Count Process Factor/- -99999 Conc Factor/- 999999 Select the function using the Function key or the Mouse User Defined eckman Coulter System Calibrator R332 * Values set for working in g/d ** Concentration of lowest and highest calibrators Ψ For determination of bac the above tests (Tb and bac) are used. A third test bac must also be entered in the general tests and the calculated tests of the test section menu (no settings required). Set this test as CACUATED TEST in the INTER TEST menu. Enter the formula (A/*a)+b, where A=bAc, =Tb and a=9.5, b=2.5. ASOSR6x92.4 24-8

TOTA b, AU27/AU54 I Reagent ID: 92 TbΨ Operation: Sample: Volume 9.5 μ Dilution μ Reagents: R Volume 3 μ Dilution μ R2 Volume μ Dilution μ Wavelength: Pri. 6 Sec. 7 END + Measuring Point : Measuring ast ast 27 inearity: ag Time: Pre-Dilution Rate: Min ast Dynamic : 7.* Correlation Factor: A On-board stability period: Max ast 23.* 3 I TbΨ rmal s: Age evel : Age Year. 2. 3. 4. 5. 6. 7. ne Selected 8. Out of Panic Value: Month evel : Unit: g/d* Decimal places: TbΨ Type Calibration A Formula: Y=AX+ Counts: Process: CONC Point : -Point Cal. Point: M Type Factor: Cal.. With CONC- CONC Factor/- Factor/- -99999 99999 Slope Check ne Advanced Calibration: Calibration Stability Period: 4 User Defined ot or ot + ottle eckman Coulter System Calibrator R332 * Values set for working in g/d. Ψ For determinationn of bac the above tests (Tb and bac) are used. A third test bac must also be entered in the general tests and the calculated tests of the test section menu ( no settings required). Set this test as CACUATED TEST in the INTER TEST menu. Enter the formula (A/*a)+b, where A= =bac, =Tb and a=9.5, b= =2.5. ASOSR6x92.4 24-8

TOTA b, AU58 System Reagent: OSR6x92 Parameters I bac Calculated Reagent ID: 92 Name: TbЖ Operation Sample Volume Pre-Dilution Rate Rgt. Volume R(R-) 7.6 4 R-2 Common Rgt. Type Wavelength Method Reaction Slope Measuring Point st Measuring Point2 st inearity imit ag Time Check R2(R2-) ne Pri 6 nm END + μ μ μ μ Dilution μ imit Diluent ottle Min. Max. Dilution μ Reagent imit Dilution μ st. ow 2..5 ast ow Dilution μ Dynamic ow 7* 23* Name ne Correlation Factor A Sec. 7 nm Factor for Maker A ast ast Onboard Stability Period 3 Day our 27 I Influence Check ipemia +++++ Icterus +++++ emolysis +++++ Parameters I bac Calculated TbЖ evel ow Specific s: From To Year Month ow. 2. 3. 4. 5. 6. 7. Standardd demographics 8. t within expected values Panic Value ow Unit g/d* Parameters Calibration Parameters Calibrators TbЖ Calibration A Calibrator Parameters Calibrator Point : Point 8: Point 9: Point : Point Cal. For. of Correction Points Master Curve Calibratorr Conc Point- Point-2 M Type Factor: -Point Calibration Point Formula: Conc Type Use Cal. Y=AX+ ow -999999 Use Master Curve ot Calibration ow Stability Reagent lank 4 Day Calibration 4 Day User defined eckman Coulter System Calibratorr R332. * Values set for working in g/d. To work in mmol/, divide by.625. ж Set this test in Common Parameter test name as CACUATED TEST. Enter the formula (A/)*a+b, where A=bA c, =Tb and a=9.5 and b=2.5 in Parameters CACUATED TEST 999999 Counts: with Conc- Cuvette. Slope Check Allowance Check Reagent lank Calibration Advanced Calibration Operation Decimal Places Interval (R/ACA) ottle/ottle our our ASOSR6x92.4 24-8