Labmax 240 / Sapphire 400 instructions

rev 427.0.2 - 2010-08-01

Chema Diagnostica
Via Campania 2/4
I-60030 Monsano | An Italy
T +39 0731 605064 | F +39 0731 605672
www.chema.com | mail@chema.com
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Labmax 240 / Sapphire 400 instructions

rev 427.0.2 - 2010-08-01

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.427.0.2 Directions for use Edition 2010-08-01 page 3 of 43

 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: ACID PHOSPHATASE (TOTAL) - Codes AC 0120 TC
Preparation: POWDER SINGLE REAGENT.
FOLLOW PREPARATION PROGRAM INDICATED IN INSERT SHEET.
Storage: REFRIGERATE AT 2-8°C
Stability: 10 DAYS

ITEM NAME # ACP

DATA INFORMATION
UNITS U/L
DECIMALS 1
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 405
SUB WAVELENGHT 2 700
METHOD HILLMAN
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0.0 9.0 0.0 0.0
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 26 41 HIGH 2.500
SAMPLE 25
REAGENT 1 VOL 250
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0 75
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 4 of 43

 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: ACID PHOSPHATASE (NON PROSTATIC) - Codes AC 0120 TC
Preparation: POWDER SINGLE REAGENT. FOLLOW PREPARATION PROGRAM INDICATED IN INSERT
SHEET. ADD THE RIGHT QUANTITY OF L-TARTRATE.
Storage: REFRIGERATE AT 2-8°C
Stability: 10 DAYS

ITEM NAME # ACP

DATA INFORMATION
UNITS U/L
DECIMALS 1
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 405
SUB WAVELENGHT 2 700
METHOD HILLMAN
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0.0 9.0 0.0 0.0
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 26 41 HIGH 2.500
SAMPLE 25
REAGENT 1 VOL 250
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0 75
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 5 of 43

 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: ALBUMIN - Codes BC 0100/ 0500 / 1000 / 1500 CH
Preparation: LIQUID READY TO USE SINGLE REAGENT
Storage: ROOM TEMPERATURE (2-30°C)
Stability: UP TO DECLARED EXPIRATION ON REAGENT LABEL

ITEM NAME # ALB

DATA INFORMATION
UNITS g/dl
DECIMALS 2
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 600
SUB WAVELENGHT 2 700
METHOD BCG
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 4.20 5.50 3.70 5.30
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 20 22 HIGH 1.000
SAMPLE 3
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 1.00 6.00
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 6 of 43

 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: ALKALINE PHOSPHATASE FL (DGKC) - Codes AL F080 / F245 / F400 / F600 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # ALP
DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 405
SUB WAVELENGHT 2 700
METHOD DGKC
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0 270 0 240
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 37 41 HIGH 1.800
SAMPLE 4
REAGENT 1 VOL 160
REAGENT 2 40
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 10 3000
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 7 of 43

 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: ALKALINE PHOSPHATASE FL (IFCC) - Codes AF F080 / F245 / F400 / F600 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # ALP
DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 405
SUB WAVELENGHT 2 700
METHOD IFCC
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 35 104 40 129
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 37 41 HIGH 1.800
SAMPLE 4
REAGENT 1 VOL 160
REAGENT 2 40
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 10 3000
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 8 of 43

 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: AMYLASE FL - Codes AM F060 / F120 / F245 CH
Preparation: LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL

ITEM NAME # AMY

DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 405
SUB WAVELENGHT 2 700
METHOD CNPG3
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0 96 0 96
URINE 0 480 0 480
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 22 28 HIGH 1.800
SAMPLE 5
REAGENT 1 VOL 200
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 3 2000
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 9 of 43

 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: AMYLASE EPS FL - Codes EA F080 / F245 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # AMY
DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 405
SUB WAVELENGHT 2 700
METHOD IFCC
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 28 100 28 100
URINE 0 460 0 460
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 38 50 HIGH 1.800
SAMPLE 6
REAGENT 1 VOL 160
REAGENT 2 40
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 3 2500
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 10

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: PANCREATIC ISOAMYLASE FL - Code PA F080 / F245 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # AMYP
DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 405
SUB WAVELENGHT 2 700
METHOD IFCC
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 13 53 13 53
URINE 0 350 0 350
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 38 50 HIGH 1.800
SAMPLE 4
REAGENT 1 VOL 160
REAGENT 2 40
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 3 2500
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 11

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: BICARBONATE FL - Code BR F060 / F245 / F400 CH
Preparation: LIQUID REAGENT READY TO USE
Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL

ITEM NAME # CO2

DATA INFORMATION
UNITS mEq/l
DECIMALS 1
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 405
SUB WAVELENGHT 2 700
METHOD PEPC
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 22 29 22 29
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 20 22 HIGH 1.000
SAMPLE 3
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 5 50
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 12

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: TOTAL BILIRUBIN FL - Code DT F125 / F500 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # BILIT
DATA INFORMATION
UNITS mg/dl
DECIMALS 1
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 505
SUB WAVELENGHT 2 700
METHOD DCA
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0.20 1.00 0.20 1.00
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 53 54 HIGH 3.000
SAMPLE 12 SUB 30 31
REAGENT 1 VOL 200
REAGENT 2 50
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0 20
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 13

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: DIRECT BILIRUBIN FL - Code DD F125 / F500 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # BILID
DATA INFORMATION
UNITS mg/dl
DECIMALS 1
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 546
SUB WAVELENGHT 2 700
METHOD DCA
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0.00 0.20 0.00 0.20
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 53 54 HIGH 3.000
SAMPLE 12 SUB 30 31
REAGENT 1 VOL 200
REAGENT 2 50
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0 13
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 14

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: CALCIUM - Code CA 0305 / 0505 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # CA
DATA INFORMATION
UNITS mg/dl
DECIMALS 2
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 570
SUB WAVELENGHT 2 700
METHOD OCP
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 8.60 10.30 8.60 10.30
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 40 42 HIGH 3.000
SAMPLE 5
REAGENT 1 VOL 150
REAGENT 2 150
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0 20
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 15

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: CALCIUM ASX - Code CA 0100 / 0500 CH
Preparation: LIQUID REAGENT READY TO USE
Storage: ROOM TEMPERATURE (2-30°C)
Stability: UNTIL EXPIRATION DATE ON LABEL

ITEM NAME # CA
DATA INFORMATION
UNITS mg/dl
DECIMALS 2
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 660
SUB WAVELENGHT 2
METHOD ARSENAZO
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 8.60 10.30 8.60 10.30
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 40 42 HIGH 3.000
SAMPLE 3
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0 20
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 16

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: CHLORIDE - Code CL 0100 / 0500 CH
Preparation: LIQUID READY TO USE SINGLE REAGENT
Storage: ROOM TEMPERATURE (2-30°C)
Stability: UNTIL EXPIRATION DATE ON LABEL

ITEM NAME # CL
DATA INFORMATION
UNITS mEq/l
DECIMALS
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 505
SUB WAVELENGHT 2 700
METHOD THIOCYANATE
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 98 110 98 110
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 50 51 HIGH 3.000
SAMPLE 3
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0 150
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 17

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: CHOLESTEROL FL - Codes CT F100 / F400 / 100F / 150F CH
Preparation: LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL

ITEM NAME # CHOL

DATA INFORMATION
UNITS mg/dl
DECIMALS 0
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 505
SUB WAVELENGHT 2 700
METHOD CHOD-PAP
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 140 200 140 200
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 33 34 HIGH 1.500
SAMPLE 3
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 50 700
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 18

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: HDL-DIRECT FL - Code HD F080 / F245 / F400 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # HDL-C
DATA INFORMATION
UNITS mg/dl
DECIMALS 1
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 600
SUB WAVELENGHT 2 700
METHOD IMMUNO-INHIBITION
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 35.3 79.5 42.0 88.0
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 53 54 HIGH 1.000
SAMPLE 3 SUB 30 31
REAGENT 1 VOL 225
REAGENT 2 75
THIRD MIX OFF FACTOR END POINT LIMIT 0.020
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 5 220
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 19

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: LDL-DIRECT FL - Code DL F080 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # LDL-C
DATA INFORMATION
UNITS mg/dl
DECIMALS 1
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 600
SUB WAVELENGHT 2 700
METHOD IMMUNO-INHIBITION
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 76 218 76 218
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 53 54 HIGH 1.000
SAMPLE 3 SUB 30 31
REAGENT 1 VOL 225
REAGENT 2 75
THIRD MIX OFF FACTOR END POINT LIMIT 0.020
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 10 400
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 20

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: CHOLINESTERASE FL (DGKC) - Codes CH F096 / F245 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # CHE
DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 405
SUB WAVELENGHT 2 700
METHOD DGKC
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 5600 11200 4200 10800
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW 1.000
VOLUME MAIN 36 42 HIGH 3.000
SAMPLE 5
REAGENT 1 VOL 250
REAGENT 2 50
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 1000 25000
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 21

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: CK-NAC FL - Codes CK F060 / F120 / F245 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # CK
DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 340
SUB WAVELENGHT 2 700
METHOD IFCC-DGKC
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 24 204 24 173
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 38 48 HIGH 2.500
SAMPLE 10
REAGENT 1 VOL 200
REAGENT 2 50
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 3 2000
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 22

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: CK-MB FL - Code MB F060 / F120 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # CKMB
DATA INFORMATION
UNITS U/L
DECIMALS 1
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 340
SUB WAVELENGHT 2 700
METHOD IFCC-DGKC
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0 24 0 24
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 40 54 HIGH 2.500
SAMPLE 10
REAGENT 1 VOL 200
REAGENT 2 50
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0 2000
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 23

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: COPPER - Code CU 0100 CH
Preparation: AS INDICATED IN INSERT SHEET
Storage: KEEP AT ROOM TEMP (MANDATORY!)
Stability: 14 DAYS

PROGRAM
ITEM NAME # CU
DATA INFORMATION
UNITS UG/DL
DECIMALS 0
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 570
SUB WAVELENGHT 2 700
METHOD DI-BR-PAESA
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 70 140 80 155
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 50 51 HIGH 1.800
SAMPLE 20
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 5 500
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 24

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: CREATININE - Code CR 0500 / 1000 / 1500 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # CREA
DATA INFORMATION
UNITS mg/dl
DECIMALS 2
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 505
SUB WAVELENGHT 2 700
METHOD JAFFE
CORRELATION
SLOPE INTER
Y= X+
1 -0.25
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0.70 1.20 0.60 1.10
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 36 48 HIGH 3.000
SAMPLE 20
REAGENT 1 VOL 150
REAGENT 2 150
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0.2 15
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 25

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: GAMMA-GT FL - Codes GT F080 / F245 / F400 / F600 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # GGT
DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 405
SUB WAVELENGHT 2 700
METHOD SZASZ
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0 50 0 30
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 37 41 HIGH 1.800
SAMPLE 25
REAGENT 1 VOL 200
REAGENT 2 50
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 3 800
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 26

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: GLUCOSE FL - Codes GL F400 / 100F / 150F CH
Preparation: LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL

ITEM NAME # GLUC

DATA INFORMATION
UNITS mg/dl
DECIMALS 0
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 505
SUB WAVELENGHT 2 700
METHOD GOD-PAP
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 70 105 70 105
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 49 50 HIGH 2.500
SAMPLE 3
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 40 500
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 27

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: GLUCOSE UV FL - Code GL F601 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # GLUC
DATA INFORMATION
UNITS mg/dl
DECIMALS 0
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 340
SUB WAVELENGHT 2 700
METHOD UV
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 70 105 70 105
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 49 50 HIGH 2.500
SAMPLE 3 SUB 30 31
REAGENT 1 VOL 240
REAGENT 2 60
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 40 700
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 28

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: GOT/AST FL - Codes GO F080 / F245 / F400 / F600 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # GOT
DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 340
SUB WAVELENGHT 2 700
METHOD IFCC
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0 35 0 31
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW 1.100
VOLUME MAIN 37 45 HIGH 2.500
SAMPLE 25
REAGENT 1 VOL 200
REAGENT 2 50
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 2 440
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 29

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: GPT/ALT FL - Codes GP F245 / F400 / F600 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # GPT
DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 340
SUB WAVELENGHT 2 700
METHOD IFCC
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0 45 0 34
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW 1.100
VOLUME MAIN 37 45 HIGH 2.500
SAMPLE 25
REAGENT 1 VOL 200
REAGENT 2 50
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 2 440
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 30

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: IRON FZ - Code FE F245 / F400 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B (READ PREPARATION IN MANUAL INSERT SHEET)

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # IRON
DATA INFORMATION
UNITS ug/dl
DECIMALS 0
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 570
SUB WAVELENGHT 2
METHOD FERROZINE
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 59 158 37 145
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 53 54 HIGH 3.000
SAMPLE 30 SUB 30 31
REAGENT 1 VOL 160
REAGENT 2 40
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 20 1000
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 31

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: LDH FL - Codes LD F060 / F120 / F245 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # LDH-P
DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 340
SUB WAVELENGHT 2 700
METHOD DGKC
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 225 450 225 450
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW 1.100
VOLUME MAIN 37 45 HIGH 2.500
SAMPLE 5
REAGENT 1 VOL 200
REAGENT 2 50
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 100 2000
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 32

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: LIPASE FL - Code LP F060 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # LIP
DATA INFORMATION
UNITS U/L
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 570
SUB WAVELENGHT 2 700
METHOD COLOUR
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0 60 0 60
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 37 45 HIGH 1.800
SAMPLE 4
REAGENT 1 VOL 200
REAGENT 2 50
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 40
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 2 800
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 33

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: MAGNESIUM - Code MG 0200 / 0500 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # MG
DATA INFORMATION
UNITS mEq/l
DECIMALS 2
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 505
SUB WAVELENGHT 2 700
METHOD CALMAGITE
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 1.30 2.10 1.30 2.10
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 40 41 HIGH 3.000
SAMPLE 3
REAGENT 1 VOL 150
REAGENT 2 150
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0.20 8.00
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 34

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: MAGNESIUM XL - Code MX 0300 / 0500 CH
Preparation: LIQUID REAGENT READY TO USE
Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL

ITEM NAME # MG
DATA INFORMATION
UNITS mEq/l
DECIMALS 2
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 546
SUB WAVELENGHT 2 700
METHOD XYLYDYL BLUE
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 1.30 2.10 1.30 2.10
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 40 41 HIGH 3.000
SAMPLE 3
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0.20 6.00
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 35

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: PHOSPHORUS - Code PH 0100 / 0500 CH
Preparation: LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL

ITEM NAME # PHOS

DATA INFORMATION
UNITS mg/dl
DECIMALS 1
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 340
SUB WAVELENGHT 2 700
METHOD MOLYBDATE UV
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 2.50 4.50 2.50 4.50
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 50 51 HIGH 3.000
SAMPLE 3
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 0.5 20.0
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 36

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: PROTEINS (TOTAL) - Codes TP 0100 / 0500 / 1000 / 1500 CH
Preparation: LIQUID READY TO USE SINGLE REAGENT
Storage: ROOM TEMPERATURE (2-30°C)
Stability: UNTIL EXPIRATION DATE ON LABEL

ITEM NAME # TP
DATA INFORMATION
UNITS g/dl
DECIMALS 2
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 546
SUB WAVELENGHT 2 700
METHOD BIURET
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 6.30 8.30 6.00 7.80
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 53 54 HIGH 2.000
SAMPLE 3
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 1.00 12.00
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 37

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: PROTEINS HS - Code HS 0100 / 0500 CH
Preparation: LIQUID READY TO USE SINGLE REAGENT
Storage: ROOM TEMPERATURE (2-30°C)
Stability: UNTIL EXPIRATION DATE ON LABEL

ITEM NAME # HS
DATA INFORMATION
UNITS mg/dl
DECIMALS 0
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 570
SUB WAVELENGHT 2 700
METHOD PYROGALLOL RED
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 53 54 HIGH 2.000
SAMPLE 3
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 2 500
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 38

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: TRIGLYCERIDES FL - Codes TR F100 / F400 / 100F / 150F CH
Preparation: LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL

ITEM NAME # TRIG

DATA INFORMATION
UNITS mg/dl
DECIMALS 0
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 505
SUB WAVELENGHT 2 700
METHOD GPO-PAP
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 0 200 0 200
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 40 41 HIGH 1.500
SAMPLE 3
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 20 1000
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 39

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: UREA UV FL - Codes AZ F080 / F245 / F400 / F600 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # UREA
DATA INFORMATION
UNITS mg/dl
DECIMALS 0
ANALYSIS
TYPE RATE
MAIN WAVELENGHT 1 340
SUB WAVELENGHT 2 700
METHOD UREASE UV
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 140 200 140 200
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW 1.100
VOLUME MAIN 34 38 HIGH 2.500
SAMPLE 3
REAGENT 1 VOL 240
REAGENT 2 60
THIRD MIX OFF FACTOR END POINT LIMIT
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%) 90
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 5 300
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 40

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: URIC ACID T FL - Code AU F402 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # UA
DATA INFORMATION
UNITS mg/dl
DECIMALS 2
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 546
SUB WAVELENGHT 2 700
METHOD URICASE-PAP
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 3.50 7.20 2.60 6.00
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 52 54 HIGH 1.500
SAMPLE 12 SUB 30 31
REAGENT 1 VOL 270
REAGENT 2 30
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 1.00 20.00
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 41

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: URIC ACID AOX FL - Code AX F100 / F250 / F600 CH
Preparation: REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B

Storage: REFRIGERATE AT 2-8°C
Stability: UNTIL EXPIRATION DATE ON LABEL
ITEM NAME # UA
DATA INFORMATION
UNITS mg/dl
DECIMALS 2
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 546
SUB WAVELENGHT 2 700
METHOD URICASE-PAP
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 3.50 7.20 2.60 6.00
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND DOUBLE START END LOW -0.010
VOLUME MAIN 52 54 HIGH 1.500
SAMPLE 12 SUB 30 31
REAGENT 1 VOL 200
REAGENT 2 50
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 1.00 20.00
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 42

��������
of 43
��
 Chema Diagnostica - Guidelines for automatic analyzers - Labmax 240 / Sapphire 400

Analyzer: Labmax 240 / Sapphire 400

Application: ZINC - Code ZN 0125 CH
Preparation: PREPARE MIXED REAGENT AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 14 DAYS

ITEM NAME # ZN
DATA INFORMATION
UNITS ug/dl
DECIMALS 0
ANALYSIS
TYPE END
MAIN WAVELENGHT 1 570
SUB WAVELENGHT 2 700
METHOD NITRO-PAPS
CORRELATION
SLOPE INTER
Y= X+
1 0
CALIBRATION
TYPE LINEAR
STANDARD
#1 USER DEFINED #4
#2 USER DEFINED #5
#3 #6
NORMAL RANGE
MALE FEMALE
LOW HIGH LOW HIGH
SERUM 70 150 70 150
URINE
PLASMA
CSF
DIALYSIS
OTHER

ASPIRATION DATA PROCESS READ ABSORBANCE LIMIT

KIND SINGLE START END LOW -0.010
VOLUME MAIN 52 53 HIGH 1.500
SAMPLE 15
REAGENT 1 VOL 300
REAGENT 2 0
THIRD MIX OFF FACTOR END POINT LIMIT 0.010
WATER BLANK
R1 BLANK 1 LINEAR CHECK(%)
BLANK CORRECTION

MONITOR PROZONE CHECK

O LEVEL POINT 1 START END LIMIT(%)
SPAN 3 FIRST
SECOND LOW
THIRD LOW

AUTO RETURN SW AUTO RETURN CONDITION (ABSORBANCE)

OFF ABSORBANCE RANGE
LOWER OFF
AUTO RETURN RANGE HIGHER OFF
OFF OFF
LOWER HIGHER PROZONE RANGE OFF
SERUM 20 1000
URINE
PLASMA
CSF
DIALYSIS
OTHER

IUS.427.0.2 Directions for use Edition 2010-08-01 page 43

��������
of 43
��