Instrumentation Laboratory ILab 300 instructions

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1 Instrumentation Laboratory ILab 300 instructions rev Chema Diagnostica Via Campania 2/4 I Monsano An Italy T F mail@chema.com

2

3 Instrumentation Laboratory ILab 300 instructions rev 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. IUS Directions for use Edition page 3 of 42

4 ACID PHOSPHATASE (TOTAL) - Codes AC 0120 TC POWDER SINGLE REAGENT. FOLLOW PREPARATION PROGRAM INDICATED IN INSERT SHEET. 10 DAYS PROGRAM Description: ACP LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 1 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Up Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: ACP 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 405 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 30 Lin limit. low: 0.0 RBL min (abs): High: 75.0 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 4 of 42

5 ALBUMIN - Codes BC 0100/ 0500 / 1000 / 1500 CH LIQUID READY TO USE SINGLE REAGENT ROOM TEMPERATURE (2-30 C) UP TO DECLARED EXPIRATION ON REAGENT LABEL Description: ALBUMIN LOW VALUES HIGH VALUES Unit: g/dl Male: Decimals: 1 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: ALB 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 620 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 3 Lin limit. low: 0.2 RBL min (abs): High: 7.0 Max (abs): Factor: N/A Calibration stab. (days): 7 N/A non applicabile AUTOCAL H IUS Directions for use Edition page 5 of 42

6 ALKALINE PHOSPHATASE FL (DGKC) - Codes AL F080 / F245 / F400 / F600 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: ALK.PHOS. LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Up Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: ALP 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 405 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 6 Lin limit. low: 0 RBL min (abs): High: 2800 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 6 of 42

7 ALKALINE PHOSPHATASE FL (IFCC) - Codes AF F080 / F245 / F400 / F600 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: ALK.PHOS. LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Up Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: ALP 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 405 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 6 Lin limit. low: 0 RBL min (abs): High: 2800 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 7 of 42

8 AMYLASE FL - Codes AM F060 / F120 / F245 CH LIQUID READY TO USE SINGLE REAGENT Description: AMYLASE LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Up Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: AMYLASE 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 405 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 6 Lin limit. low: 0 RBL min (abs): High: 2000 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 8 of 42

9 AMYLASE EPS FL - Codes EA F080 / F245 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: AMYLASE LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Up Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: AMYLASE 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 405 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 10 Lin limit. low: 0 RBL min (abs): High: 1500 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 9 of 42

10 PANCREATIC ISOAMYLASE FL - Code PA F080 / F245 CH REAGENT # 1 - USE REAGENT A REAGENT # 2 - USE REAGENT B Description: ISOAMYLASE LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Up Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: ISOAMY1 ISOAMY2 Depl.limit (abs): Lot Number: Filter 1 (nm): 405 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 5 Lin limit. low: 0 RBL min (abs): High: 2500 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 10 of 42

11 BICARBONATE FL - Code BR F060 / F245 / F400 CH LIQUID REAGENT READY TO USE Description: BICARBONATE LOW VALUES HIGH VALUES Unit: mmol/l Male: Decimals: 1 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: CO2 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 405 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 4 Lin limit. low: 5 RBL min (abs): High: 50 Max (abs): Factor: N/A Calibration stab. (days): 10 N/A non applicabile IUS Directions for use Edition page 11 of 42

12 TOTAL BILIRUBIN FL - Code DT F125 / F500 CH REAGENT # 1 - USE REAGENT A REAGENT # 2 - USE REAGENT B Description: BILI-T LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 2 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: BT1 BT/D2 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 546 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 25 Lin limit. low: 0.00 RBL min (abs): High: Max (abs): Factor: N/A Calibration stab. (days): 1 N/A non applicabile Sample blank: Yes AUTOCAL H IUS Directions for use Edition page 12 of 42

13 DIRECT BILIRUBIN FL - Code DD F125 / F500 CH REAGENT # 1 - USE REAGENT A REAGENT # 2 - USE REAGENT B Description: BILI-D LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 2 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: BD1 BT/D2 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 546 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 25 Lin limit. low: 0.00 RBL min (abs): High: Max (abs): Factor: N/A Calibration stab. (days): 1 N/A non applicabile Sample blank: Yes AUTOCAL H IUS Directions for use Edition page 13 of 42

14 CALCIUM - Code CA 0305 / 0505 CH REAGENT # 1 - USE REAGENT B REAGENT # 2 - USE REAGENT A Description: CALCIUM LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 2 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: CA1 CA2 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 578 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 15 Lin limit. low: 0.80 RBL min (abs): High: Max (abs): Factor: N/A Calibration stab. (days): 1 N/A non applicabile Sample blank: Yes AUTOCAL H IUS Directions for use Edition page 14 of 42

15 CALCIUM ASX - Code CA 0100 / 0500 CH LIQUID REAGENT READY TO USE ROOM TEMPERATURE (2-30 C) Description: CALCIUM LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 2 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: CALCIUM 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 620 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 4 Lin limit. low: 0.80 RBL min (abs): High: Max (abs): Factor: N/A Calibration stab. (days): 1 N/A non applicabile AUTOCAL H IUS Directions for use Edition page 15 of 42

16 CHLORIDE - Code CL 0100 / 0500 CH LIQUID READY TO USE SINGLE REAGENT ROOM TEMPERATURE (2-30 C) Description: CHLORIDE LOW VALUES HIGH VALUES Unit: meq/l Male: Decimals: 0 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: CL 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 492 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 3 Lin limit. low: 20 RBL min (abs): High: 200 Max (abs): Factor: N/A Calibration stab. (days): 7 N/A non applicabile AUTOCAL H IUS Directions for use Edition page 16 of 42

17 CHOLESTEROL FL - Codes CT F100 / F400 / 100F / 150F CH LIQUID READY TO USE SINGLE REAGENT Description: CHOLESTEROL LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 0 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: CHOL 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 510 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 4 Lin limit. low: 5 RBL min (abs): High: 700 Max (abs): Factor: N/A Calibration stab. (days): 10 N/A non applicabile AUTOCAL H IUS Directions for use Edition page 17 of 42

18 HDL-DIRECT FL - Code HD F080 / F245 / F400 CH REAGENT # 1 - USE REAGENT A REAGENT # 2 - USE REAGENT B Description: HDL-C LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 0 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: HDL1 HDL2 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 620 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 3 Lin limit. low: 2 RBL min (abs): High: 220 Max (abs): Factor: N/A Calibration stab. (days): 7 N/A non applicabile Sample blank: Yes AUTOCAL H IUS Directions for use Edition page 18 of 42

19 LDL-DIRECT FL - Code DL F080 CH REAGENT # 1 - USE REAGENT A REAGENT # 2 - USE REAGENT B Description: LDL-C LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 0 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: LDL1 LDL2 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 620 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 3 Lin limit. low: 2 RBL min (abs): High: 400 Max (abs): Factor: N/A Calibration stab. (days): 7 N/A non applicabile Sample blank: Yes AUTOCAL H IUS Directions for use Edition page 19 of 42

20 CHOLINESTERASE FL (DGKC) - Codes CH F096 / F245 CH REAGENT # 1 - USE REAGENT A REAGENT # 2 - USE REAGENT B Description: CHOLINESTERASE LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Down Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: CHE1 CHE2 Depl.limit (abs): Lot Number: Filter 1 (nm): 405 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 6 Lin limit. low: 0 RBL min (abs): High: Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 20 of 42

21 CK-NAC FL - Codes CK F060 / F120 / F245 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: CK LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Up Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: CK 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 340 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 12 Lin limit. low: 0 RBL min (abs): High: 2000 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 21 of 42

22 CK-MB FL - Code MB F060 / F120 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: CKMB LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Up Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: CKMB 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 340 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 12 Lin limit. low: 0 RBL min (abs): High: 1600 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO CKMB IUS Directions for use Edition page 22 of 42

23 COPPER - Code CU 0100 CH MIX REAGENTS ACCORDING TO INSERT SHEET KEEP AT ROOM TEMP (MANDATORY!) 14 DAYS PROGRAM Description: COPPER LOW VALUES HIGH VALUES Unit: µg/dl Male: Decimals: 0 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: COPPER 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 578 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 20 Lin limit. low: 2 RBL min (abs): High: 500 Max (abs): Factor: N/A Calibration stab. (days): 1 N/A non applicabile STANDARD NEL KIT IUS Directions for use Edition page 23 of 42

24 CREATININE - Code CR 0500 / 1500 CH REAGENT # 1 - USE REAGENT A REAGENT # 2 - USE REAGENT B Description: CREATININE LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 2 Female: LIS Code: ** Children: Reaction type: Fixed time Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Up Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: CA1 CA2 Depl.limit (abs): Lot Number: Filter 1 (nm): 510 First limit (abs): Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Linear factor: 0.98 Rinse (µl): Bicr. factor: 1.00 Fit: N/A Sample (µl): 20 Lin limit. low: 0.02 RBL min (abs): High: Max (abs): Factor: 0.00 Calibration stab. (days): 3 N/A non applicabile Sample blank: N/A AUTOCAL H IUS Directions for use Edition page 24 of 42

25 GAMMA-GT FL - Codes GT F080 / F245 / F400 / F600 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: GAMMA GT LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Up Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: GGT 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 405 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 30 Lin limit. low: 0 RBL min (abs): High: 800 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 25 of 42

26 GLUCOSE FL - Codes GL F400 / 100F / 150F CH LIQUID READY TO USE SINGLE REAGENT Description: GLUCOSE LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 0 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: GLUC 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 510 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 4 Lin limit. low: 5 RBL min (abs): High: 550 Max (abs): Factor: N/A Calibration stab. (days): 10 N/A non applicabile AUTOCAL H IUS Directions for use Edition page 26 of 42

27 GLUCOSE UV FL - Code GL F601 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: GLUCOSE LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 0 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: GLUC 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 340 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 4 Lin limit. low: 5 RBL min (abs): High: 1000 Max (abs): Factor: N/A Calibration stab. (days): 10 N/A non applicabile AUTOCAL H IUS Directions for use Edition page 27 of 42

28 GOT/AST FL - Codes GO F080 / F245 / F400 / F600 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: GOT/AST LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Down Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: GOT 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 340 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 30 Lin limit. low: 0 RBL min (abs): High: 440 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 28 of 42

29 GPT/ALT FL - Codes GP F080 / F245 / F400 / F600 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: GPT/ALT LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Down Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: GPT 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 340 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 30 Lin limit. low: 0 RBL min (abs): High: 440 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 29 of 42

30 IRON FZ - Code FE F245 / F400 CH REAGENT # 1 - USE REAGENT A REAGENT # 2 - USE REAGENT B (READ PREPARATION IN MANUAL INSERT SHEET) Description: IRON LOW VALUES HIGH VALUES Unit: µg/dl Male: Decimals: 0 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: IRON1 IRON2 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 578 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 75 Lin limit. low: 0 RBL min (abs): High: 1000 Max (abs): Factor: N/A Calibration stab. (days): 1 N/A non applicabile Sample blank: Yes AUTOCAL H IUS Directions for use Edition page 30 of 42

31 LDH FL - Codes LD F060 / F120 / F245 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: LDH-P LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Down Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: LDH 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 340 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 4 Lin limit. low: 30 RBL min (abs): High: 4000 Max (abs): Calculation. model: Factor RBL stability (days): 1 ** definito dall operatore Factor: Calibration stab. (days): 99 N/A non applicabile NESSUNO IUS Directions for use Edition page 31 of 42

32 LIPASE FL - Code LP F060 CH REAGENT # 1 - USE REAGENT A REAGENT # 2 - USE REAGENT B Description: LIPASE LOW VALUES HIGH VALUES Unit: UI Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Kinetic Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Up Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: LIP1 LIP2 Depl.limit (abs): Lot Number: Filter 1 (nm): 578 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: Sample (µl): 3 Lin limit. low: 0 RBL min (abs): High: 250 Max (abs): Factor: N/A Calibration stab. (days): 99 N/A non applicabile FORNITO CON IL KIT IUS Directions for use Edition page 32 of 42

33 MAGNESIUM - Code MG 0200 / 0500 CH REAGENT # 1 - USE REAGENT B REAGENT # 2 - USE REAGENT A Description: MAGNESIUM LOW VALUES HIGH VALUES Unit: meq/l Male: Decimals: 2 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: MG1 MG2 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 510 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 6 Lin limit. low: 0.00 RBL min (abs): High: 8.00 Max (abs): Factor: N/A Calibration stab. (days): 1 N/A non applicabile Sample blank: Yes AUTOCAL H IUS Directions for use Edition page 33 of 42

34 MAGNESIUM XL - Code MX 0300 / 0500 CH LIQUID REAGENT READY TO USE Description: MAGNESIUM LOW VALUES HIGH VALUES Unit: meq/l Male: Decimals: 2 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: MG 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 546 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 3 Lin limit. low: 0.00 RBL min (abs): High: 8.00 Max (abs): Factor: N/A Calibration stab. (days): 1 N/A non applicabile Sample blank: Yes AUTOCAL H IUS Directions for use Edition page 34 of 42

35 PHOSPHORUS - Code PH 0100 / 0500 CH LIQUID READY TO USE SINGLE REAGENT Description: PHOSPHORUS LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 2 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: PH 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 340 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 4 Lin limit. low: 0.10 RBL min (abs): High: Max (abs): Factor: N/A Calibration stab. (days): 7 N/A non applicabile AUTOCAL H IUS Directions for use Edition page 35 of 42

36 PROTEINS (TOTAL) - Codes TP 0100 / 0500 / 1000 / 1500 CH LIQUID READY TO USE SINGLE REAGENT ROOM TEMPERATURE (2-30 C) Description: PROTEINS LOW VALUES HIGH VALUES Unit: g/dl Male: Decimals: 2 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: TP 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 546 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 4 Lin limit. low: 0.10 RBL min (abs): High: Max (abs): Factor: N/A Calibration stab. (days): 10 N/A non applicabile AUTOCAL H IUS Directions for use Edition page 36 of 42

37 PROTEINS HS - Code HS 0100 / 0500 CH LIQUID READY TO USE SINGLE REAGENT ROOM TEMPERATURE (2-30 C) Description: HS PROTEINS LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 0 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: HS 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 620 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 3 Lin limit. low: 2 RBL min (abs): High: 500 Max (abs): Factor: N/A Calibration stab. (days): 5 N/A non applicabile STANDARD NEL KIT XX IUS Directions for use Edition page 37 of 42

38 TRIGLYCERIDES FL - Codes TR F100 / F400 / 100F / 150F CH LIQUID READY TO USE SINGLE REAGENT Description: TRIGLYCERIDES LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 0 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: TRIG 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 510 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 4 Lin limit. low: 5 RBL min (abs): High: 1000 Max (abs): Factor: N/A Calibration stab. (days): 10 N/A non applicabile AUTOCAL H IUS Directions for use Edition page 38 of 42

39 UREA UV FL - Codes AZ F080 / F245 / F400 / F600 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: UREA LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 0 Female: LIS Code: ** Children: Reaction type: Fixed time Predilut.-> S.+R. 1-> Reag. 2-> Reag. 3-> Incubation -> Read Direction: Down Times (sec): E.P. limit (abs): N/A Dil./Rgt. Code: UREA 0 Depl.limit (abs): Lot Number: Filter 1 (nm): 340 First limit (abs): Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Linear factor: 0.95 Rinse (µl): Bicr. factor: 1.00 Fit: N/A Sample (µl): 4 Lin limit. low: 3 RBL min (abs): High: 300 Max (abs): Factor: 0.00 Calibration stab. (days): 10 N/A non applicabile Sample blank: N/A AUTOCAL H IUS Directions for use Edition page 39 of 42

40 URIC ACID T FL - Code AU F402 CH MIX REAGENTS ACCORDING TO INSERT SHEET Description: URIC ACID LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 2 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: URIC 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 546 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 10 Lin limit. low: 0.50 RBL min (abs): High: Max (abs): Factor: N/A Calibration stab. (days): 10 N/A non applicabile AUTOCAL H IUS Directions for use Edition page 40 of 42

41 URIC ACID AOX FL - Code AX F100 / F250 / F600 CH REAGENT # 1 - USE REAGENT A REAGENT # 2 - USE REAGENT B Description: URIC ACID LOW VALUES HIGH VALUES Unit: mg/dl Male: Decimals: 2 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: URIC1 URIC2 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 546 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 20 Lin limit. low: 0 RBL min (abs): High: 35 Max (abs): Factor: N/A Calibration stab. (days): 1 N/A non applicabile Sample blank: Yes AUTOCAL H IUS Directions for use Edition page 41 of 42

42 ZINC - Code ZN 0125 CH PREPARE MIXED REAGENT AS INDICATED IN INSERT SHEET 14 DAYS Description: ZINK LOW VALUES HIGH VALUES Unit: µg/dl Male: Decimals: 0 Female: LIS Code: ** Children: Direction: Up Times (sec): E.P. limit (abs): Dil./Rgt. Code: ZINC 0 Depl.limit (abs): N/A Lot Number: Filter 1 (nm): 578 First limit (abs): N/A Ratio/Vol (µl): 1/ Filter 2 (nm): (none) Fit: N/A Sample (µl): 20 Lin limit. low: 2 RBL min (abs): High: 1000 Max (abs): Factor: N/A Calibration stab. (days): 1 N/A non applicabile STANDARD NEL KIT IUS Directions for use Edition page 42 of 42

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