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Number:VR—VM/RD—2—1210—00 12 / 47


GuangzhouWanfu Biotechnology Co., Ltd.


Number:VR—VM/RD—2—1210—00


Fully AutomaticImmunohistochemical Staining MachinePA-3600


Verification Report


Report Development


Hardware and New Technology Department / Prepared by: Date:


Report Review


Hardware and New Technology Department / Reviewer: Date:


Instrument Development Department 1 / Reviewer: Date:


Report Approved


Total person in charge of company verification: Date:


Number:VR—VM/RD—2—1120—00 13 / 47


Table of Contents


Directory 1


Chapter 1: Overview 2


1.1 Verification Purpose 2


1.2 Test basis 2


1.3 Test Information 2


1.3.1 Instrument Use Environment 2


1.3.2 Prototype 2


1.3.3 Test Equipment 2


1.4 Test Results 2


1.4.1 Test Results 2


Chapter 2: Test Records 5


2.1 Appearance and Structure Verification 5


2.2 Instrument Function Verification 5


2.3 Basic Performance 7


2.3.1 Temperature Accuracy of the Staining Module Heating Component 7


2.3.2 Temperature Fluctuation of the Staining Module Heating Component 11


2.3.3 Reagent Addition Accuracy 14


2.3.4 Reagent Addition Volume Repeatability 16


2.4 Network Security Verification 17


2.4.1 Data Interface 17


2.4.2 User Access Control 18


2.5 Climate Environment Testing 19


Chapter 1: Overview


1.1 Verification Purpose


Fornewly developedfully automated immunohistochemical staining machinePA-3600developmentprototype stagetoappearance, performanceand climate environment adaptability to be verifiedevaluation.


1.2 Test Basis


《Fully Automated Immunohistochemical Staining Machine PA-3600Test Plan》Document Number:VS—VM/RD—1—1210—00


1.3 Test information


1.3.1 Instrument usage environment


1)Operating temperature: 18℃~30 ℃;


2) Relative humidity: 20%~70% (no condensation);


3) Atmospheric pressure:Less than2000m;


4) Rated voltage:AC100240V;


5)Frequency :50Hz/60Hz


6) Avoid direct exposure to strong light;


7) Use in a well-grounded environment and avoid dust, acidic volatile gases, vibration and strong electromagnetic interference.


1.3.2 Prototype


The sample numbers are:PA36002009100001(referred to as 1#)


1.3.3 Test Equipment


Equipment Calibration Number


Test equipment


Model Number


Calibration date


Validity Period

08-53


Data acquisition instrument

DAQ970A

2024-03-28


One year

/


Analytical Balance

ME104E

2024-07-08


One year

/


Hydrometer

DENSITO

2024-03-28


One year

/


Thermohygrometer

/

2024-03-28


One year

/


Walk-in Temperature and Humidity Test Chamber

/

2024-03-28


One year


1.4 Test Results


Test Results 1.4.1


Serial Number


Test Project


Test function phenomenon


Result Judgment


Notes


Appearance structure


The prototype appearance should be clean, free of cracks, burrs or scratches, and the text and markings on the panel should be clear and accurate


2) The prototype's moving parts operate smoothly without any jamming or sudden jumps. The operation is stable and there is no significant noise


3) Fastener connections shall be strong and reliable, with no looseness

合格

/


Functionality testing


1)Used for sample processing before pathological analysis, fully automated completion of dewaxing, antigen retrieval, staining and fluorescence in situ hybridization (FISH) detection pretreatment, post-hybridization washing;


2)The fully automated immunohistochemical staining machine has 36 staining sites;


3)The fully automated immunohistochemical staining machine has 40 reagent positions;


4)Equipped with slide QR code scanning system;


5)The software interface can display the buffer volume in real time;


6)Has the function of classifying and storing waste liquid;


7)has a patient information management system;


8)Has reagent information management system

合格

/


Dyeing Module Heating ComponentTemperatureAccuracy


At18、24、30、30/70%RHenvironment, the dyeing module meets the requirements at the temperature control points (37℃, 65℃, 85℃, 101℃): the maximum (MAX) and minimum (MIN) of the stable internal temperature should be within the range of T±2℃.

合格

/


Dyeing module heating componenttemperaturefluctuation


Operating under conditions of 18℃, 24℃, 30℃, and 30℃/70%RH, the staining module meets the requirements at all temperature control points (37℃, 65℃, 85℃, 101℃): Temperature fluctuation < 0.5℃.

合格

/


Reagent Addition Accuracy


Reagent addition volume control points (100μL, 130μL, 240μL, 370μL, 500μL)all meet:addition volume deviation Pv≤3%.

合格

/


Reagent Addition Repeatability


Reagent addition volume control points (100μL, 130μL, 240μL, 370μL, 500μL)all meet: repeatability CV ≤ 5%.

合格

/


Data Interface


Dyeing machine data interface includes network interface and serialinterface, where the network interface is used to realize communication between the dyeing machine and the computer, serialinterfaceisused by the manufacturer to debug the instrument, users can't use it.


1) Wired networks primarily use manufacturer-defined protocols for transmission.


2) Serial interface: Transmission protocol: RS232; Data format: Baud rate 115200,no parityevenparity, no TS/CTS, 8data bits, nostop bit.

合格

/


User Access Control


User types: regular user, administrator user


User Authentication: Upon boot-up, user permissions are determined based on the defined username. After entering the software, functionalities are restricted or opened based on the user's permissions


Regular users can perform dyeing operations; administrator users can perform dyeing operations and can add or delete regular user accounts.

合格

/


Low-temperature test at rated operating conditions


Prototypestructureappearance, temperature control, sample loading performance, and functionality all meet the technical requirements.

合格

/


High temperature test for rated operating conditions


Mockupstructureappearance, temperature control, sample loading performance and functionality all meet the technical requirements.

合格

/


Rated operating humid heat test


Prototypestructureappearance, temperature control, sample loading performance and function all meet the technical requirements.

合格

/


Low-temperature storage test


After the testprototypestructureappearancetemperature control, sample loading performance and functions all meet the technical requirements.

合格

/


High temperature storage test


After the testprototypestructureappearancetemperature control, sample loading performance and function all meet the technical requirements.

合格

/


Damp Heat Storage Test


Aftertheprototypestructureappearancetemperaturecontrolsampleadditionperformanceandfunctionallmeetthetechnicalrequirements

合格

/


Number:VR—VM/RD—2—1120—00 16 / 23


Chapter Two: Test Records


2.1 Appearance and StructureVerification


2.1.1 Test Information


Mockup Quantity: 3 units Mockup Number: 1#、2#、3#


Testing Tool: Visual Inspection Tester: Yang Qingyun


2.1.2 Test Method


Inspect3prototype units, visually inspect the appearance, structure, keys, fastener connections, etc. of the units in natural light with normal or corrected vision, and confirm whether the appearance and structure meet the design requirements.


2.1.3 Judgment Criteria


1) The appearance should be clean and free of cracks, burrs or scratches, and the text and markings on the panel should be clear and accurate;


2) Fully automated immunohistochemical staining machineMoving parts should be smooth, without jamming or jumping, working smoothly and without significant noise;


3) Fastener connections should be strong and reliable, and should not be loose.


2.1.4 Test Results


The prototype appearance should be clean, free of cracks, burrs or scratches, and the text and markings on the panel should be clear and accurate


2) The prototype's moving parts operate smoothly without any jamming or sudden jumps. The operation is stable and there is no significant noise


3) Fastener connections should be strong and reliable, without looseness.


2.2 Instrument Function Verification


2.1.1 Test Information


Mockup quantity: 3 units Mockup number: 1#, 2#, 3#


Test Tool: Visual Inspection Tester: Yang Qingyun


2.1.2 Test Method


Check3prototype units and system software functionality, perform full-process testing according to the following requirements:


Visually check if the fully automated immunohistochemical staining machine has36positionstomeet the design requirements.


Visually inspect and manually install the reagent rack, confirming the number of reagent bottles that can be installed


Is there a QR code scanning system visible?


Visually inspect the software interface for the buffer bottle options


Visually assess whether there are two categories for storing waste liquid drums;


Detect whether the software interface has a patient information management system;


7) Check whether the software interface has a reagent information management system.


2.1.3 Judgment Criteria


1)It can be used for sample processing before pathological analysis, fully automatically completing including dewaxing, antigen retrieval, staining, and fluorescence in situ hybridization (FISH) detection pretreatment, post-hybridization washing;


2)The fully automated immunohistochemical staining machine has 36 staining positions;


3) The fully automated immunohistochemical staining machine has 40 reagent positions;


4)Equipped with slide QR code scanning system;


5)The software interface can display the buffer volume in real time;


6)has the function of classifying and storing waste liquid;


7)Has a patient information management system;


8) Possesses a reagent information management system.


2.1.4 Test Results


1)Can be used for sample processing before pathological analysis, automatically completing the whole process including dewaxing, antigen repair, staining and fluorescence in situ hybridization (FISH) detection pretreatment, hybridization after washing.


2)The fully automated immunohistochemical staining machine has 36 staining positions;


3)The fully automated immunohistochemical staining machine has 40 reagent positions;


4)equipped with slide QR code scanning system;


5)The software interface can display the buffer volume in real time;


6)Has the function of classifying and storing waste liquid;


7)Has a patient information management system;


8) Has a reagent information management system.


2.1.5 Test data

/


Number:VR—VM/RD—2—1120—00 16 / 23


2.3 Basic Performance


2.3.1 Dyeing Module Heating ComponentsTemperatureAccuracy


2.3.1.1 Test Information


Mockup quantity: 1 unit Mockup number: 1#


Testing tools:DAQ970A data acquisition instrument Tester: Yang Qingyun


2.3.1.2 Test Method


Use a temperature measuring slide (with a temperature probe fixed) to test according to the following method at ambient temperatures of 18℃, 24℃, 30℃, and 30℃/70%RH:


The lower machine controls 36modules to heat up together. Prepare the test slides before testing. The working area of the slide is fixed1NTC temperature sensor. The NTC should be as close to the upper surface as possible to ensure the surface of the slide is flat.


Turn on the sample stage, place the slide in place and control the cover slip according to table2.3.1.2.1to press down to the preset position and reset, then select the preset position for the cover slip to press down according to different test temperature points and control the heating element to reach the temperature control point T corresponding to the preset position.


After the temperature stabilizes (please check the temperature stabilization time table for the stabilization time of each temperature point), collect data at an interval of 1S for a total time of 5min. Select the maximum value (MAX) and minimum value (MIN) of the temperature within the temperature stabilization period, respectively.


Table2.3.1.2.1 Preset Location and Temperature Control Point Correspondence Table:


Temperature Set Point (°C)


Press down the cover to the preset position


Stabilization Time (min)

37

A7

3

65

A4

5

85

A3

8

101

A3

10


2.3.1.3 Judgment Criteria


At environmental temperatures of18℃, 24℃, 30, the staining module requires that at temperature control points T of 37℃, 65℃, 85℃, and 101℃, the NTC temperature of all data points (maximum (MAX) and minimum (MIN) temperature within the stable temperature) of the temperature sensor glass in the reaction zone should be within the range of T±2℃.


2.3.1.4 Test Results


Test results all meet 2.3.1.3judgment criteria requirements, specific data see 2.3.1.5.


2.3.1.5 Test Data


2.3.1.5.1Test data:


Table 2.3.1.5.1


37℃ setpoint stable temperature (unit/℃)


Module Number


18°C Low Temperature


Room temperature environment 24℃


High temperature environment 30


30℃/70%RHEnvironment

 


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius

0#

37.23

37.06

37.30

37.07

37.20

36.96

37.26

36.97

1#

37.30

36.98

37.11

37.00

37.28

37.02

37.28

36.91

2#

37.21

36.91

37.23

37.04

37.27

36.95

37.19

37.02

3#

37.26

36.97

37.24

37.00

37.11

36.94

37.27

37.06

4#

37.13

36.97

37.27

37.01

37.28

37.05

37.11

37.04

5#

37.15

37.08

37.28

36.91

37.27

37.01

37.16

37.08

6#

37.29

37.03

37.21

37.03

37.30

36.94

37.22

36.94

7#

37.14

36.92

37.22

36.97

37.16

37.00

37.28

37.03

8#

37.10

36.96

37.26

37.08

37.15

36.99

37.11

36.90

9#

37.24

36.90

37.20

37.02

37.14

37.06

37.21

36.97

10#

37.25

37.01

37.20

37.04

37.21

36.96

37.18

36.95

11#

37.26

36.94

37.24

37.05

37.26

37.01

37.19

36.90

12#

37.14

37.01

37.24

37.09

37.26

36.98

37.17

36.97

13#

37.21

36.90

37.12

36.98

37.29

37.07

37.30

37.00

14#

37.22

36.91

37.11

36.93

37.17

37.07

37.16

36.91

15#

37.13

36.96

37.11

36.96

37.16

37.01

37.12

36.91

16#

37.26

37.06

37.11

36.94

37.26

37.01

37.20

37.02

17#

37.28

37.05

37.23

37.04

37.28

36.98

37.17

36.96

18#

37.25

36.90

37.28

37.01

37.25

36.95

37.29

36.91

19#

37.15

37.05

37.20

37.08

37.16

36.90

37.17

37.01

20#

37.16

37.03

37.11

37.05

37.30

37.06

37.18

37.02

21#

37.12

36.93

37.22

36.94

37.25

37.05

37.19

37.09

22#

37.13

36.92

37.21

36.91

37.10

36.93

37.14

37.06

23#

37.26

37.06

37.12

36.97

37.10

36.94

37.22

37.09

24#

37.11

37.00

37.29

37.05

37.26

36.92

37.30

36.92

25#

37.12

37.00

37.23

37.09

37.30

37.07

37.28

36.92

26#

37.20

36.90

37.10

36.92

37.17

37.00

37.25

36.98

27#

37.17

37.02

37.15

37.09

37.22

37.01

37.24

37.08

28#

37.10

37.03

37.28

37.07

37.28

36.95

37.24

37.03

29#

37.29

36.98

37.17

37.09

37.26

36.97

37.13

36.92

30#

37.30

36.93

37.11

36.93

37.19

37.07

37.23

36.95

31#

37.15

36.99

37.26

37.05

37.16

36.91

37.18

37.08

32#

37.19

37.09

37.19

36.96

37.16

37.06

37.27

36.90

33#

37.14

36.91

37.26

36.93

37.15

36.94

37.23

37.03

34#

37.15

37.08

37.17

37.04

37.20

37.08

37.24

36.98

35#

37.12

36.91

37.30

37.01

37.15

36.90

37.11

36.96


Table 2.3.1.5.2


65℃ temperature control point stable temperature (unit/℃)


Module Number

 


18°C Low Temperature


Room temperature environment 24℃


High temperature environment 30


30℃/70%RHenvironment


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius

0#

65.15

64.76

65.10

64.87

65.10

64.72

65.08

64.74

1#

65.00

64.87

65.23

64.90

65.26

64.75

65.09

64.89

2#

65.21

64.81

65.14

64.74

65.04

64.73

65.04

64.78

3#

65.00

64.80

65.11

64.71

65.14

64.75

65.25

64.89

4#

65.00

64.85

65.14

64.81

65.13

64.87

65.09

64.86

5#

65.26

64.76

65.27

64.89

65.11

64.88

65.24

64.86

6#

65.20

64.79

65.23

64.83

65.24

64.73

65.30

64.86

7#

65.15

64.76

65.07

64.76

65.07

64.82

65.21

64.87

8#

65.17

64.74

65.14

64.89

65.10

64.90

65.25

64.77

9#

65.08

64.83

65.26

64.85

65.12

64.84

65.04

64.85

10#

65.20

64.76

65.10

64.73

65.06

64.74

65.29

64.84

11#

65.12

64.87

65.28

64.79

65.16

64.78

65.02

64.70

12#

65.30

64.70

65.10

64.80

65.26

64.73

65.00

64.83

13#

65.27

64.77

65.23

64.84

65.20

64.71

65.12

64.70

14#

65.20

64.85

65.18

64.76

65.15

64.75

65.26

64.70

15#

65.30

64.72

65.27

64.84

65.04

64.71

65.04

64.72

16#

65.15

64.75

65.28

64.86

65.11

64.82

65.04

64.74

17#

65.02

64.86

65.24

64.87

65.27

64.84

65.13

64.74

18#

65.18

64.76

65.20

64.81

65.24

64.79

65.27

64.90

19#

65.17

64.83

65.05

64.76

65.01

64.70

65.16

64.79

20#

65.17

64.86

65.29

64.73

65.09

64.76

65.17

64.73

21#

65.18

64.83

65.13

64.73

65.28

64.81

65.09

64.76

22#

65.22

64.74

65.02

64.72

65.08

64.74

65.09

64.73

23#

65.29

64.71

65.16

64.88

65.30

64.71

65.30

64.81

24#

65.16

64.78

65.27

64.86

65.27

64.80

65.10

64.86

25#

65.05

64.77

65.29

64.89

65.16

64.82

65.14

64.82

26#

65.30

64.84

65.26

64.78

65.16

64.70

65.28

64.89

27#

65.17

64.75

65.07

64.75

65.02

64.81

65.13

64.78

28#

65.04

64.82

65.24

64.70

65.08

64.76

65.15

64.83

29#

65.00

64.80

65.14

64.83

65.01

64.75

65.27

64.81

30#

65.24

64.74

65.29

64.90

65.11

64.73

65.20

64.72

31#

65.21

64.86

65.03

64.81

65.10

64.88

65.00

64.82

32#

65.04

64.81

65.19

64.87

65.05

64.84

65.18

64.75

33#

65.17

64.82

65.25

64.78

65.27

64.81

65.08

64.74

34#

65.18

64.80

65.19

64.81

65.27

64.71

65.26

64.76

35#

65.04

64.81

65.30

64.75

65.24

64.88

65.07

64.84


Table 2.3.1.5.3


85℃ Temperature control point, stable temperature (unit/℃)


Module Number

 


18°C Low Temperature


Room temperature environment 24℃


High temperature environment 30


30℃/70%RHenvironment


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius

0#

85.28

84.63

85.10

84.74

85.15

84.61

85.29

84.76

1#

85.10

84.78

85.27

84.64

85.18

84.64

85.05

84.66

2#

85.29

84.69

85.15

84.65

85.03

84.74

85.04

84.78

3#

85.11

84.61

85.26

84.75

85.06

84.74

85.15

84.60

4#

85.14

84.72

85.00

84.80

85.22

84.79

85.03

84.74

5#

85.21

84.61

85.26

84.77

85.20

84.66

85.21

84.62

6#

85.12

84.72

85.29

84.66

85.28

84.65

85.13

84.63

7#

85.11

84.69

85.10

84.64

85.19

84.69

85.01

84.66

8#

85.21

84.69

85.26

84.80

85.25

84.65

85.00

84.66

9#

85.10

84.78

85.01

84.73

85.09

84.76

85.19

84.66

10#

85.02

84.75

85.02

84.64

85.11

84.71

85.07

84.66

11#

85.10

84.60

85.14

84.67

85.05

84.65

85.22

84.71

12#

85.24

84.67

85.02

84.80

85.17

84.60

85.08

84.71

13#

85.30

84.65

85.17

84.66

85.17

84.79

85.08

84.67

14#

85.16

84.68

85.13

84.74

85.14

84.62

85.19

84.71

15#

85.20

84.60

85.10

84.67

85.28

84.65

85.25

84.73

16#

85.23

84.71

85.23

84.60

85.24

84.70

85.19

84.75

17#

85.10

84.68

85.07

84.64

85.27

84.69

85.13

84.77

18#

85.22

84.63

85.02

84.66

85.25

84.79

85.07

84.61

19#

85.10

84.79

85.02

84.64

85.26

84.66

85.07

84.65

20#

85.08

84.80

85.19

84.72

85.24

84.78

85.22

84.68

21#

85.21

84.70

85.11

84.64

85.27

84.73

85.30

84.79

22#

85.03

84.73

85.03

84.69

85.01

84.77

85.07

84.73

23#

85.08

84.66

85.21

84.63

85.27

84.75

85.30

84.80

24#

85.01

84.60

85.21

84.79

85.12

84.75

85.26

84.61

25#

85.27

84.62

85.19

84.76

85.21

84.60

85.04

84.76

26#

85.00

84.66

85.27

84.75

85.29

84.75

85.01

84.65

27#

85.20

84.66

85.21

84.64

85.05

84.72

85.10

84.64

28#

85.12

84.78

85.23

84.66

85.21

84.60

85.30

84.80

29#

85.18

84.75

85.28

84.77

85.28

84.73

85.22

84.67

30#

85.29

84.69

85.14

84.69

85.15

84.75

85.03

84.79

31#

85.01

84.60

85.11

84.68

85.17

84.66

85.05

84.65

32#

85.19

84.60

85.00

84.78

85.09

84.69

85.25

84.71

33#

85.19

84.73

85.24

84.74

85.29

84.60

85.21

84.74

34#

85.07

84.62

85.24

84.65

85.20

84.60

85.09

84.64

35#

85.10

84.67

85.12

84.66

85.16

84.78

85.02

84.60


Table 2.3.1.5.4


101℃ Control Point Stable Temperature (Unit/℃)


Module Number


18°C Low Temperature


Room temperature environment 24℃


High temperature environment 30


30℃/70%RHenvironment

 


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius

0#

100.96

100.34

100.99

100.65

101.00

100.49

100.96

100.45

1#

100.99

100.09

100.94

100.42

100.91

100.34

100.91

100.46

2#

100.72

100.03

100.97

100.62

100.97

100.41

100.98

100.26

3#

100.64

100.01

100.93

100.25

100.93

100.68

100.99

100.40

4#

100.90

100.16

100.96

100.69

100.99

100.48

100.96

100.55

5#

100.99

100.07

100.92

100.36

100.93

100.47

100.97

100.33

6#

100.56

100.08

100.99

100.36

100.92

100.56

100.99

100.37

7#

100.96

100.06

100.90

100.42

100.91

100.53

100.92

100.47

8#

100.88

100.16

100.90

100.40

100.99

100.35

100.92

100.58

9#

100.69

100.05

100.92

100.69

100.90

100.21

101.00

100.41

10#

100.65

100.00

100.96

100.43

100.98

100.47

100.94

100.43

11#

100.94

100.32

100.94

100.60

100.97

100.27

100.90

100.56

12#

100.51

100.01

100.99

100.60

100.94

100.68

101.00

100.49

13#

100.81

99.99

100.95

100.38

100.93

100.43

100.96

100.35

14#

100.82

100.24

101.00

100.57

100.93

100.46

100.98

100.41

15#

100.81

100.04

100.98

100.35

100.91

100.50

101.00

100.62

16#

100.56

100.12

100.95

100.39

100.92

100.31

100.96

100.51

17#

100.82

100.28

100.90

100.24

100.94

100.65

100.95

100.30

18#

100.86

100.21

100.94

100.60

100.99

100.69

100.95

100.67

19#

100.57

100.31

100.95

100.24

100.92

100.23

100.93

100.28

20#

100.75

100.33

100.96

100.63

100.97

100.58

101.00

100.26

21#

100.58

100.29

100.97

100.55

100.97

100.33

100.99

100.36

22#

100.66

100.34

100.96

100.20

100.90

100.65

100.91

100.55

23#

101.00

100.12

100.90

100.25

100.98

100.21

100.96

100.30

24#

100.81

100.15

100.99

100.42

100.90

100.37

100.92

100.49

25#

100.90

100.11

100.95

100.27

100.97

100.65

100.98

100.24

26#

100.53

100.28

100.95

100.38

100.93

100.58

100.90

100.44

27#

100.86

100.33

100.95

100.48

100.91

100.64

100.95

100.45

28#

100.64

100.06

100.91

100.32

100.94

100.35

100.98

100.59

29#

100.92

100.09

100.90

100.39

100.95

100.49

100.98

100.33

30#

101.00

100.20

100.93

100.32

100.93

100.52

101.00

100.59

31#

100.78

100.14

100.96

100.27

101.00

100.56

100.94

100.24

32#

100.59

100.25

100.95

100.20

100.96

100.48

100.90

100.34

33#

100.83

100.31

100.99

100.68

100.92

100.39

100.94

100.20

34#

100.67

100.29

100.95

100.63

100.93

100.70

100.98

100.39

35#

100.64

100.17

101.00

100.48

101.00

100.48

100.98

100.29


2.3.2 Dyeing Module Heating ComponentTemperatureFluctuation


2.3.2.1 Test Information


Sample quantity: 1 unit Sample number: 1#


Test Tool:DAQ970A Data Acquisition Instrument Tester: Yang Qingyun


2.3.2.2 Test Method


Use a temperature-measuring slide (with a temperature probe attached) to test in the following way at ambient temperatures of 18℃, 24℃, 30℃ and 30℃/70%RH:


The lower computer controls all modules to heat up together. Prepare the test slide before testing. The NTC temperature sensor is fixed in the working area of the slide, and the NTC should be as close to the upper surface as possible to ensure that the surface of the slide is flat. Turn on the prototype, place the slide in place, and control the cover plate according to table2.3.1.2.1 to press down to the preset position and then reset. Then, according to the different test temperature points, select thepreset position for pressing down the cover plate, and control the heating plate to reach the corresponding temperature control point T.


Wait until the temperature stabilizes (please check the temperature stabilization time table for the stabilization time of each temperature point), collect the temperature, the collection interval is 1S, the total collection time is 5min, calculate the temperature fluctuation according to the formula (2), and record the temperature measurement data.


Related Calculation Formulas:

Tf = ( Tfmax - Tfmin ) / 2………………………………(2)


Where:


Tf ------ Temperature fluctuation, unit is ;


Tfmax ------ Test point is stablethe highest measured temperature value within 5 minutes, unit is ;


Tfmin ------ Test point is stablethe measured minimum temperature value within 5 minutes, unit is .


2.3.2.3 Judgment Criteria


Table2.2.2.3.1 Temperature Fluctuation Judgment Standard


Ambient Temperature(℃)


Temperature Set Point (°C)


Temperature Fluctuation Range (°C)


At18,24,30and30/70%RHenvironment temperatures, respectively, during testing

37


Less than 0.5°C

65

85

101


2.3.2.4 Test Results


Meet 2.3.2.3criteria requirements.


2.3.2.5 Test data


(1) Temperature Fluctuation:


Table 2.3.2.5.1


Temperature Fluctuation(Unit/℃)


Module Number


Low temperature 18℃environment


Room temperature environment 24℃below

 

37

65


85°C


101°C

37

65


85°C


101°C

0#

0.085

0.195

0.325

0.310

0.115

0.115

0.180

0.170

1#

0.16

0.065

0.160

0.450

0.055

0.165

0.315

0.260

2#

0.15

0.200

0.300

0.345

0.095

0.200

0.250

0.175

3#

0.145

0.100

0.250

0.315

0.12

0.200

0.255

0.340

4#

0.08

0.075

0.210

0.370

0.13

0.165

0.100

0.135

5#

0.035

0.250

0.300

0.460

0.185

0.190

0.245

0.280

6#

0.13

0.205

0.200

0.240

0.09

0.200

0.315

0.315

7#

0.11

0.195

0.210

0.450

0.125

0.155

0.230

0.240

8#

0.07

0.215

0.260

0.360

0.09

0.125

0.230

0.250

9#

0.17

0.125

0.160

0.320

0.09

0.205

0.140

0.115

10#

0.12

0.220

0.135

0.325

0.08

0.185

0.190

0.265

11#

0.16

0.125

0.250

0.310

0.095

0.245

0.235

0.170

12#

0.065

0.300

0.285

0.250

0.075

0.150

0.110

0.195

13#

0.155

0.250

0.325

0.410

0.07

0.195

0.255

0.285

14#

0.155

0.175

0.240

0.290

0.09

0.210

0.195

0.215

15#

0.085

0.290

0.300

0.385

0.075

0.215

0.215

0.315

16#

0.1

0.200

0.260

0.220

0.085

0.210

0.315

0.280

17#

0.115

0.080

0.210

0.270

0.095

0.185

0.215

0.330

18#

0.175

0.210

0.295

0.325

0.135

0.195

0.180

0.170

19#

0.05

0.170

0.155

0.130

0.06

0.145

0.190

0.355

20#

0.065

0.155

0.140

0.210

0.03

0.280

0.235

0.165

21#

0.095

0.175

0.255

0.145

0.14

0.200

0.235

0.210

22#

0.105

0.240

0.150

0.160

0.15

0.150

0.170

0.380

23#

0.1

0.290

0.210

0.440

0.075

0.140

0.290

0.325

24#

0.055

0.190

0.205

0.330

0.12

0.205

0.210

0.285

25#

0.06

0.140

0.325

0.395

0.07

0.200

0.215

0.340

26#

0.15

0.230

0.170

0.125

0.09

0.240

0.260

0.285

27#

0.075

0.210

0.270

0.265

0.03

0.160

0.285

0.235

28#

0.035

0.110

0.170

0.290

0.105

0.270

0.285

0.295

29#

0.155

0.100

0.215

0.415

0.04

0.155

0.255

0.255

30#

0.185

0.250

0.300

0.400

0.09

0.195

0.225

0.305

31#

0.08

0.175

0.205

0.320

0.105

0.110

0.215

0.345

32#

0.05

0.115

0.295

0.170

0.115

0.160

0.110

0.375

33#

0.115

0.175

0.230

0.260

0.165

0.235

0.250

0.155

34#

0.035

0.190

0.225

0.190

0.065

0.190

0.295

0.160

35#

0.105

0.115

0.215

0.235

0.145

0.275

0.230

0.260


Table 2.3.2.5.2


Temperature fluctuation(unit/℃)


Module Number


High temperature30℃environment


30℃/70%RHenvironment

 

37

65


85°C


101°C

37

65


85°C


101°C

0#

0.120

0.190

0.270

0.255

0.145

0.170

0.265

0.255

1#

0.130

0.255

0.270

0.285

0.185

0.100

0.195

0.225

2#

0.160

0.155

0.145

0.280

0.085

0.130

0.130

0.360

3#

0.085

0.195

0.160

0.125

0.105

0.180

0.275

0.295

4#

0.115

0.130

0.215

0.255

0.035

0.115

0.145

0.205

5#

0.130

0.115

0.270

0.230

0.040

0.190

0.295

0.320

6#

0.180

0.255

0.315

0.180

0.140

0.220

0.250

0.310

7#

0.080

0.125

0.250

0.190

0.125

0.170

0.175

0.225

8#

0.080

0.100

0.300

0.320

0.105

0.240

0.170

0.170

9#

0.040

0.140

0.165

0.345

0.120

0.095

0.265

0.295

10#

0.125

0.160

0.200

0.255

0.115

0.225

0.205

0.255

11#

0.125

0.190

0.200

0.350

0.145

0.160

0.255

0.170

12#

0.140

0.265

0.285

0.130

0.100

0.085

0.185

0.255

13#

0.110

0.245

0.190

0.250

0.150

0.210

0.205

0.305

14#

0.050

0.200

0.260

0.235

0.125

0.280

0.240

0.285

15#

0.075

0.165

0.315

0.205

0.105

0.160

0.260

0.190

16#

0.125

0.145

0.270

0.305

0.090

0.150

0.220

0.225

17#

0.150

0.215

0.290

0.145

0.105

0.195

0.180

0.325

18#

0.150

0.225

0.230

0.150

0.190

0.185

0.230

0.140

19#

0.130

0.155

0.300

0.345

0.080

0.185

0.210

0.325

20#

0.120

0.165

0.230

0.195

0.080

0.220

0.270

0.370

21#

0.100

0.235

0.270

0.320

0.050

0.165

0.255

0.315

22#

0.085

0.170

0.120

0.125

0.040

0.180

0.170

0.180

23#

0.080

0.295

0.260

0.385

0.065

0.245

0.250

0.330

24#

0.170

0.235

0.185

0.265

0.190

0.120

0.325

0.215

25#

0.115

0.170

0.305

0.160

0.180

0.160

0.140

0.370

26#

0.085

0.230

0.270

0.175

0.135

0.195

0.180

0.230

27#

0.105

0.105

0.165

0.135

0.080

0.175

0.230

0.250

28#

0.165

0.160

0.305

0.295

0.105

0.160

0.250

0.195

29#

0.145

0.130

0.275

0.230

0.105

0.230

0.275

0.325

30#

0.060

0.190

0.200

0.205

0.140

0.240

0.120

0.205

31#

0.125

0.110

0.255

0.220

0.050

0.090

0.200

0.350

32#

0.050

0.105

0.200

0.240

0.185

0.215

0.270

0.280

33#

0.105

0.230

0.345

0.265

0.100

0.170

0.235

0.370

34#

0.060

0.280

0.300

0.115

0.130

0.250

0.225

0.295

35#

0.125

0.180

0.190

0.260

0.075

0.115

0.210

0.345


2.3.3 Reagent Addition Accuracy


2.3.3.1 Test Information


Mockup Quantity: 1 Mockup Number: 1#


Testing Tools:Analytical Balance (XSR105DU)、Density Meter (DENSITO Tester: Yang Qingyun


2.3.3.2 Test Method


(1)Weigh the prepared centrifuge tubes with different labels before adding the sample using a high-precision balance (precision: 0.0001g) to obtain the weight M 1. After the pump initialization, measure the density of deionized water using a densimeter, denoted as ρ deionized water. Then, inject the deionized water into the centrifuge tube and weigh the tube again to obtain M 2. According to the reagent volume control points: 100μL, 130μL, 240μL, 370μL, 500μL, compare the weight of the centrifuge tube before and after adding the liquid. Repeat the measurement 5 times.


(2)Let the control variable be VR, calculate the actual sample volume Vi according to formula (2), and calculate the sample dispensing deviation percentage PV according to formula (3).


Related Calculation Formulas:

V = M2M1ρ去离子水 ………………………………………(2)

Pv = |ViVRVR|×100% ……………………………(3)


Where:


We ----------------- actual sample volume(i=1,2,3,4,5);


VR ----------------Control amount


M1 ----------------Weight of centrifuge tube before loading


M2 ----------------Weight of centrifuge tube after sample addition ;


ρdeionized water------------Density of deionized water (measured using a hydrometer);


Pv -----------------Percentage deviation of the spit sample.


2.3.3.3 Judgment Criteria


Reagent addition volumes at 100μL, 130μL, 240μL, 370μL, 500μL control points require: Pvdeviation ≤3%.


2.3.3.4 Test Results


Meet 2.3.3.3judgment criteria, specific deviation data see 2.3.3.5.


2.2.3.5 Test Data


Test times


Pre-tare weighing


Tare Weight


Actual annotation samples


Density


Annotated sample


Nominal value


Deviation


Standard requirements


Sample size1


1.03793 grams

1.13539g

97.460mg


0.9968 milligrams per microliter


97.77 microliters


100 microliters

-2.23%

≤|±3%|


Sample size2

1.04587g

1.14598g

100.110mg


0.9968 milligrams per microliter


100.43 microliters


100 microliters

0.43%

≤|±3%|


Sample Size3


1.03837 grams


1.13785 grams

99.480mg


0.9968 milligrams per microliter


99.80 microliters


100 microliters

-0.20%

≤|±3%|


Sample size4


1.03852 grams

1.13746g

98.940mg


0.9968 milligrams per microliter


99.26 microliters


100 microliters

-0.74%

≤|±3%|


Sample size5


1.03083 grams

1.12846g

97.630mg


0.9968 milligrams per microliter


97.94 microliters


100 microliters

-2.06%

≤|±3%|


Mean

98.724mg


0.9968 milligrams per microliter


99.04 microliters


100 microliters

-0.96%

≤|±3%|

CV

1.17%

1.17%

1.5%


Test times


Pre-tare weighing


Tare Weight


Actual annotation samples


Density


Annotated sample


Nominal value


Deviation


Standard requirements


Sample Size1


1.03789 grams


1.16672 grams

128.830mg


0.9968 milligrams per microliter


129.24 microliters


130 microliters

-0.58%

≤|±3%|


Sample size2


1.04571 grams

1.17568g

129.970mg


0.9968 milligrams per microliter


130.39 microliters


130 microliters

0.30%

≤|±3%|


Sample size3

1.03868g

1.16548g


126,800 mg


0.9968 milligrams per microliter


127.21 microliters


130 microliters

-2.15%

≤|±3%|


Sample size4

1.03827g


1.16635 grams

128.080mg


0.9968 milligrams per microliter


128.49 microliters


130 microliters

-1.16%

≤|±3%|


Sample size5


1.03105 grams


1.15811 grams


127.060 mg


0.9968 milligrams per microliter


127.47 microliters


130 microliters

-1.95%

≤|±3%|


Mean

 

 

128.148mg


0.9968 milligrams per microliter


128.56 microliters


130 microliters

-1.11%

≤|±3%|

CV

 

 

1.02%

 

1.02%

 

 

1.5%


Test times


Pre-tare weighing


Tare Weight


Actual annotation samples


Density


Annotated sample


Nominal value


Deviation


Standard requirements


Sample size1

1.03796g

1.27430g

236.340mg


0.9968 milligrams per microliter


237.10 microliters


240 microliters

-1.21%

≤|±3%|


Sample size2


1.04582 grams

1.27935g


233.530 mg


0.9968 milligrams per microliter


234.28 microliters


240 microliters

-2.38%

≤|±3%|


Sample size3


1.03829 grams

1.27323g


234.940 mg


0.9968 milligrams per microliter


235.69 microliters


240 microliters

-1.79%

≤|±3%|


Sample Size4


1.03812 grams

1.27869g

240.570mg


0.9968 milligrams per microliter


241.34 microliters


240 microliters

0.56%

≤|±3%|


Sample size5


1.03148 grams

1.26889g

237.410mg


0.9968 milligrams per microliter


238.17 microliters


240 microliters

-0.76%

≤|±3%|


Mean

 

 


236.558 mg


0.9968 milligrams per microliter


237.32 microliters


240 microliters

-1.12%

≤|±3%|

CV

 

 

1.13%

 

1.13%

 

 

1.5%


Test times


Pre-tare weighing


Tare Weight


Actual annotation samples


Density


Annotated sample


Nominal value


Deviation


Standard requirements


Sample size1

1.03900g

1.40454g


365.540 mg


0.9968 milligrams per microliter


366.71 microliters


370 microliters

-0.89%

≤|±3%|


Sample size2

1.04633g

1.41317g


366.840 mg


0.9968 milligrams per microliter


368.02 microliters


370 microliters

-0.54%

≤|±3%|


Sample size3

1.03856g


1.40414 grams

365.580mg


0.9968 milligrams per microliter


366.75 microliters


370 microliters

-0.88%

≤|±3%|


Sample size4


1.03877 grams


1.40476 grams


365.990 mg


0.9968 milligrams per microliter


367.16 microliters


370 microliters

-0.77%

≤|±3%|


Sample size5

1.03091g

1.39955g


368.640 mg


0.9968 milligrams per microliter


369.82 microliters


370 microliters

-0.05%

≤|±3%|


Mean

 

 

366.518mg


0.9968 milligrams per microliter


367.69 microliters


370 microliters

-0.62%

≤|±3%|

CV

 

 

0.35%

 

0.35%

 

 

1.5%


Test times


Pre-tare weighing


Tare Weight


Actual annotation samples


Density


Annotated sample


Nominal value


Deviation


Standard requirements


Sample size1


1.03845 grams

1.53578g

497.330mg


0.9968 milligrams per microliter


498.93 microliters


500 microliters

-0.21%

≤|±3%|


Sample size2


1.04573 grams

1.54288g


497.150 mg


0.9968 milligrams per microliter


498.75 microliters


500 microliters

-0.25%

≤|±3%|


Sample size3


1.03824 grams


1.53554 grams

497.300mg


0.9968 milligrams per microliter


498.90 microliters


500 microliters

-0.22%

≤|±3%|


Sample Size4

1.03809g

1.53681g

498.720mg


0.9968 milligrams per microliter


500.32 microliters


500 microliters

0.06%

≤|±3%|


Sample Size5


1.03093 grams

1.52843g


497,500 mg


0.9968 milligrams per microliter


499.10 microliters


500 microliters

-0.18%

≤|±3%|


Mean

 

 

497.600mg


0.9968 milligrams per microliter


499.20 microliters


500 microliters

-0.16%

≤|±3%|

CV

 

 

0.13%

 

0.13%

 

 

1.5%


2.3.4 Reagent Addition Volume Repeatability


2.3.4.1 Test Information


Prototype Quantity: 1 unit Prototype Number: 1#


Test tools:Analytical balance (XSR105DU ), density meter (DENSITO ) Tester: Yang Qingyun


2.3.4.2 Test Method


(1)Weigh the prepared centrifuge tubes with different labels using a high-precision balance (accuracy 0.0001g) before adding samples. After initializing the pump, use a densimeter to measure the density of deionized waterρdeionized water. Theninject the above-mentioned controlled amount of deionized water into the centrifuge tubes, according to the control points for reagent addition: 100μL, 130μL, 240μL, 370μL500μL. Compare the mass of the centrifuge tubes before and after adding liquid, and repeat the measurement 5 times.


(2)Let the control volume be VR, calculate the actual sample volume Vi according to formula (2), calculate the average value of the actual sample volume VAVE according to formula (4), calculate the standard deviation VSTDof the actual sample volume according to formula (5), and calculate the coefficient of variation CV according to formula (6).


Related Calculation Formulas:

VAVE = V1+V2+V3+V4+V55 ………………………(4)

Vstd = 1n−1i=1n(VVAVE)2 …………………(5)

CV = VSTDVAVE×100% ……………………………(6)


Where:


We ------------------- actual sample volume(i=1,2,3,4,5)


VAVE --------------Average actual sample volume;


VSTD --------------Actual sample volume standard deviation;


CV ----------------Coefficient of variation.


2.3.4.3 Judgment criteria


Reagent addition volume at control points of 100μL, 130μL, 240μL, 370μL, 500μL requires: CV5%.


2.3.4.4 Test results


Meet 2.2.4.3criteria, see 2.3.4.5 for details.


2.2.4.5 Test data


Sample volume repeatability


Theoretical Added Amount


Standard100μL


Standard130μL


Standard240μL


Standard370μL


Standard500μL

CV

1.17%

1.02%

1.13%

0.35%

0.13%


2.4 Network Security Verification


2.4.1 Data Interface


2.4.1.1 Test Information


Sample quantity: 1 unit Sample number: 1#


Test Tools:Network cable, RS232 converter cable Tester: Yang Qingyun


2.4.1.2 Test Method


Check if the test prototype has data interfaces including network port and serial interface ; check if the network port can be used through a network cable to realize communication between the dyeing machine and the computer, serialportinterfaceusingtransmission protocol: RS232; data format: baud rate 115200, no oddevenparity, no TS/CTS, 8bit data bits, nostop bitsconnect to the debugging test software for debugging;


2.4.1.3 Judgment Criteria


The dyeing machine data interface includes network port and serialinterface, where the network port is used to realize communication between the dyeing machine and the computer,seriesportinterfaceis used by the manufacturer for instrument debugging, users cannot use it.


1) Wired networks primarily use manufacturer-defined protocols for transmission.


2) Serial Interface: Transmission protocol: RS232; Data format: Baud rate 115200,no parityevenparity, no TS/CTS, 8data bits, nostop bits.


2.4.1.4 Test results


The dyeing machine data interface includes a network interface and serialinterface, where the network interface is used to realize communication between the dyeing machine and the computer, serialinterfaceis used by the manufacturer to debug the instrument, and users cannot use it.


1) Wired networks can be used to transmit data using manufacturer-defined protocols, connecting to testing software systems.


2) Serial Interface: Transmission Protocol: RS232; Data Format: Baud Rate 115200, noparitycheck、no TS/CTS, 8data bits、nostop bit.


2.1.5 Test data

/


2.4.2 User Access Control


2.4.2.1 Test Information


Sample quantity: 1 Sample number: 1#


Test tools:Network cable Tester: Yang Qingyun


2.4.2.2 Test Method


Communicate between the dyeing machine and the computer through the network port, log in to the system test software to check if the following conditions are met:


1) User Types: Regular User, Administrator User;


2)User authentication: When the device powers on, user permissions are determined based on the defined username. After entering the software, functions are closed and opened according to user permissions.


3) Normal users have permission to perform dyeing operations; administrator users have permission to perform dyeing operations and can add or delete normal user accounts;


2.4.2.3 Judgment criteria


1) User Types: Regular User, Administrator User;


2)User Identification: At startup, user privileges are determined based on the defined username. After entering the software, the functions are closed or opened based on the user privileges;


3) Ordinary users can perform dyeing operations; Administrators can perform dyeing operations and can add or delete ordinary user accounts.


2.4.2.4 Test Results


1) User types include: general users, administrator users;


2)User Authentication: At startup, user permissions are determined based on the defined username. Once the software is launched, functions are locked or unlocked based on user permissions.


3) Ordinary users can perform dyeing operations; Administrators can perform dyeing operations and can add or delete ordinary user accounts.


2.2.5 Test Data

/


2.5 Climate Environment Testing


2.5.1.1 Test Information


Sample Quantity: 1 unit Sample Number: 1#


Testing tools:Walk-in environmental chamber Testers: Yang Qingyun and Hu Zhanshuo


2.5.1.2 Test Method


Take one sample machine,according to《GB/T14710-2009 Medical Electrical Equipment - Environmental Requirements and Test Methods》climate environmental test group I requirementsto conduct the test,the specific test items and test conditions are shown in Table 2.5.1.


Test items are as follows:


A、Inspect the appearance and structure of the prototype.


B、Check thestartupprototypeand system software functions, perform end-to-end testing;


C、Check all external device interfaces;


D. Measure each test 5 times using deionized water.Control points for reagent dosage:100μL, 130μL, 240μL, 370μL, 500μL;


E、AccordingtoTable.2.3.1.2.1, test36modulesseparatelyunderallheating conditionswiththetemperaturecontrol pointsat37℃65℃85and 101℃ and record the results


2.5.1.3 Judgment criteria


Appearance inspection


1) The appearance should be clean and free of cracks, burrs or scratches, and the text and markings on the panel should be clear and accurate;


2) The moving parts of the fully automated immunohistochemical staining machine should run smoothly, without jamming or sudden jumping, and operate steadily with no significant noise


3) Fastener links should be strong and reliable and should not be loose..


Instrument function testing:


1)Used for sample processing before pathological analysis, fully automatically completes dewaxing, antigen retrieval, staining and fluorescence in situ hybridization (FISH) detection pretreatment, post-hybridization washing;


2) The fully automatic immunohistochemical staining machine has 36 staining positions;


3)The fully automatic immunohistochemical staining machine has 40 reagent positions;


4)equipped with a slide barcode scanning system;


5)The software interface can display the buffer volume in real time;


6)It has the function of classifying and storing waste liquid;


7)have a patient information management system;


8)Has a reagent information management system


Instrument Performance Testing:


The temperature control range of the heating component of the dyeing module is: 37℃, 65℃, 85℃, 101℃.


Temperature accuracy is ±2°C, and temperature fluctuation is less than 0.5°C.


2.3.2 Reagent Dosage


Reagent addition volume control range is: 100μL, 130μL, 240μL, 370μL,500μL.


The accuracy of the added amount is ≤3%, and the coefficient of variation CV is ≤5%.


Table 2.5.1 Climate Environment Test Items and Requirements


Experimental project


Experiment Requirements


Inspection Items


Continuous


Time


(h)


Restore


Time


(h)


Energized


State


Experiment


Conditions


Initial


Detection


Middle


Detection


Finally


Detection


Power supply voltage

V

AC198V

AC242V


Rated Work


Low-temperature test

4


Energized during testing


18°C

ABCDE

ABC


Low Temperature Storage Test

4

8


Energize after testing


-40°F

ABC

AC220V


Rated Work


High temperature test

4


Energized during testing


86°F

ABC


Run the experiment

4


Energized during testing


86°F

ABC


High temperature storage test

4

8


Energize after testing


55°C

--

ABC

AC220V


Rated Work


Humidity and Heat Test

4


Energized during testing


86°F

70%RH

ABC

AC220V


Humid heatstoragetest

48

24


Energize after testing


104°F


93% relative humidity

ABCDE

AC220V


2.5.1.4 Test Results


Meet 2.5.1.3judgment criteria requirements.


2.5.1.5 Test data


1) Detailed data before the experiment can be viewed in Chapter 2.3.


2)Test data after experiment:


Table 2.5.1.5.1


Temperature Accuracy After Testing


Module Number


37℃ control point


65℃ control point


85℃ Temperature Control Point


101℃ Control Point

 


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius


MAX/°C


Minimum / Degrees Celsius

0#

37.29

36.99

65.30

64.75

85.10

84.79

100.93

100.53

1#

37.15

36.94

65.09

64.78

85.30

84.63

100.97

100.49

2#

37.29

37.05

65.06

64.86

85.17

84.63

100.98

100.44

3#

37.15

37.02

65.19

64.85

85.00

84.63

100.97

100.69

4#

37.17

36.97

65.09

64.87

85.27

84.63

100.97

100.64

5#

37.29

36.91

65.19

64.70

85.05

84.70

100.92

100.24

6#

37.26

37.00

65.06

64.76

85.10

84.76

100.91

100.67

7#

37.24

36.97

65.14

64.76

85.08

84.73

100.93

100.21

8#

37.28

36.96

65.30

64.78

85.26

84.74

100.99

100.41

9#

37.23

36.91

65.25

64.84

85.01

84.60

100.93

100.42

10#

37.22

36.98

65.18

64.85

85.01

84.71

100.93

100.27

11#

37.13

36.93

65.03

64.85

85.29

84.67

100.92

100.49

12#

37.11

36.93

65.25

64.81

85.19

84.64

100.99

100.68

13#

37.12

37.09

65.03

64.83

85.00

84.64

100.95

100.42

14#

37.17

37.04

65.11

64.85

85.25

84.77

100.97

100.57

15#

37.16

37.09

65.23

64.83

85.25

84.66

100.95

100.22

16#

37.30

37.00

65.29

64.87

85.15

84.70

101.00

100.28

17#

37.29

36.92

65.15

64.79

85.28

84.77

100.98

100.63

18#

37.13

37.05

65.03

64.79

85.26

84.70

100.99

100.50

19#

37.18

37.00

65.10

64.79

85.18

84.68

100.96

100.62

20#

37.23

36.92

65.16

64.72

85.11

84.66

100.93

100.26

21#

37.27

36.94

65.20

64.78

85.02

84.76

101.00

100.33

22#

37.11

36.98

65.29

64.72

85.25

84.71

100.91

100.32

23#

37.18

37.09

65.23

64.90

85.28

84.68

100.92

100.31

24#

37.15

36.97

65.27

64.82

85.13

84.65

100.91

100.21

25#

37.16

37.02

65.04

64.86

85.04

84.70

100.90

100.31

26#

37.24

37.04

65.06

64.84

85.30

84.78

100.95

100.70

27#

37.13

37.09

65.24

64.90

85.01

84.68

101.00

100.57

28#

37.13

37.00

65.02

64.84

85.16

84.78

100.96

100.41

29#

37.15

37.07

65.12

64.88

85.27

84.66

100.91

100.38

30#

37.11

36.99

65.15

64.86

85.29

84.63

100.96

100.68

31#

37.18

37.02

65.12

64.70

85.11

84.73

100.91

100.70

32#

37.18

36.91

65.15

64.83

85.07

84.66

100.93

100.44

33#

37.28

36.94

65.00

64.79

85.18

84.80

100.90

100.20

34#

37.14

37.00

65.03

64.72

85.04

84.76

100.98

100.42

35#

37.27

36.91

65.03

64.85

85.08

84.62

100.98

100.60


Table 2.5.1.5.2


Temperature Fluctuation After Experiment


Module Number


37℃ control point


65℃ control point


85℃ Temperature Control Point


101℃ Control Point

0#

0.150

0.275

0.155

0.200

1#

0.105

0.155

0.335

0.240

2#

0.120

0.100

0.270

0.270

3#

0.065

0.170

0.185

0.140

4#

0.100

0.110

0.320

0.165

5#

0.190

0.245

0.175

0.340

6#

0.130

0.150

0.170

0.120

7#

0.135

0.190

0.175

0.360

8#

0.160

0.260

0.260

0.290

9#

0.160

0.205

0.205

0.255

10#

0.120

0.165

0.150

0.330

11#

0.100

0.090

0.310

0.215

12#

0.090

0.220

0.275

0.155

13#

0.015

0.100

0.180

0.265

14#

0.065

0.130

0.240

0.200

15#

0.035

0.200

0.295

0.365

16#

0.150

0.210

0.225

0.360

17#

0.185

0.180

0.255

0.175

18#

0.040

0.120

0.280

0.245

19#

0.090

0.155

0.250

0.170

20#

0.155

0.220

0.225

0.335

21#

0.165

0.210

0.130

0.335

22#

0.065

0.285

0.270

0.295

23#

0.045

0.165

0.300

0.305

24#

0.090

0.225

0.240

0.350

25#

0.070

0.090

0.170

0.295

26#

0.100

0.110

0.260

0.125

27#

0.020

0.170

0.165

0.215

28#

0.065

0.090

0.190

0.275

29#

0.040

0.120

0.305

0.265

30#

0.060

0.145

0.330

0.140

31#

0.080

0.210

0.190

0.105

32#

0.135

0.160

0.205

0.245

33#

0.170

0.105

0.190

0.350

34#

0.070

0.155

0.140

0.280

35#

0.180

0.090

0.230

0.190


Table2.5.1.5.3 Sample Volume Accuracy and Repeatability


Test times


Pre-tare weighing


Tare Weight


Actual annotation samples


Density


Annotated sample


Nominal value


Deviation


Standard requirements


Sample size1

1.03792g


1.13607 grams

98.150mg


0.9968 milligrams per microliter


98.47 microliters


100 microliters

-1.53%

≤|±3%|


Sample size2

1.04577g

1.14645g


100.680 milligrams


0.9968 milligrams per microliter


101.00 microliters


100 microliters

1.00%

≤|±3%|


Sample Size3


1.03825 grams


1.13782 grams

99.570mg


0.9968 milligrams per microliter


99.89 microliters


100 microliters

-0.11%

≤|±3%|


Sample Size4


1.03816 grams

1.13651g


98.350 mg


0.9968 milligrams per microliter


98.67 microliters


100 microliters

-1.33%

≤|±3%|


Sample size5

1.03088g

1.12952g

98.640mg


0.9968 milligrams per microliter


98.96 microliters


100 microliters

-1.04%

≤|±3%|


Mean

 

 


99.078 milligrams


0.9968 milligrams per microliter


99.40 microliters


100 microliters

-0.60%

≤|±3%|

CV

 

 

1.06%

 

1.06%

 

 

1.5%


Test times


Pre-tare weighing


Tare Weight


Actual annotation samples


Density


Annotated sample


Nominal value


Deviation


Standard requirements


Sample size1

1.03792g

1.16409g

126.170mg


0.9968 milligrams per microliter


126.58 microliters


130 microliters

-2.63%

≤|±3%|


Sample size2


1.04576 grams

1.17572g


129.960 mg


0.9968 milligrams per microliter


130.38 microliters


130 microliters

0.29%

≤|±3%|


Sample size3


1.03824 grams


1.16475 grams


126.510 milligrams


0.9968 milligrams per microliter


126.92 microliters


130 microliters

-2.37%

≤|±3%|


Sample size4


1.03812 grams

1.16639g

128.270mg


0.9968 milligrams per microliter


128.68 microliters


130 microliters

-1.01%

≤|±3%|


Sample size5


1.03080 grams

1.15777g

126.970mg


0.9968 milligrams per microliter


127.38 microliters


130 microliters

-2.02%

≤|±3%|


Mean

 

 

127.576mg


0.9968 milligrams per microliter


127.99 microliters


130 microliters

-1.55%

≤|±3%|

CV

 

 

1.22%

 

1.22%

 

 

1.5%


Test times


Pre-tare weighing


Tare Weight


Actual annotation samples


Density


Annotated sample


Nominal value


Deviation


Standard requirements


Sample size1


1.04429 grams

1.27774g

233.450mg


0.9968 milligrams per microliter


234.20 microliters


240 microliters

-2.42%

≤|±3%|


Sample Size2

1.05105g

1.28963g


238.580 mg


0.9968 milligrams per microliter


239.35 microliters


240 microliters

-0.27%

≤|±3%|


Sample size3


1.04414 grams

1.27977g

235.630mg


0.9968 milligrams per microliter


236.39 microliters


240 microliters

-1.51%

≤|±3%|


Sample size4

1.04541g

1.28287g

237.460mg


0.9968 milligrams per microliter


238.22 microliters


240 microliters

-0.74%

≤|±3%|


Sample size5

1.03790g

1.27413g

236.230mg


0.9968 milligrams per microliter


236.99 microliters


240 microliters

-1.25%

≤|±3%|


Mean

 

 

236.270mg


0.9968 milligrams per microliter


237.03 microliters


240 microliters

-1.24%

≤|±3%|

CV

 

 

0.82%

 

0.82%

 

 

1.5%


Test times


Pre-tare weighing


Tare Weight


Actual annotation samples


Density


Annotated sample


Nominal value


Deviation


Standard requirements


Sample Size1


1.04465 grams

1.40909g


364.440 mg


0.9968 milligrams per microliter


365.61 microliters


370 microliters

-1.19%

≤|±3%|


Sample Size2

1.05361g

1.42052g

366.910mg


0.9968 milligrams per microliter


368.09 microliters


370 microliters

-0.52%

≤|±3%|


Sample Size3


1.04452 grams

1.40719g

362.670mg


0.9968 milligrams per microliter


363.83 microliters


370 microliters

-1.67%

≤|±3%|


Sample size4


1.04498 grams


1.41144 grams

366.460mg


0.9968 milligrams per microliter


367.64 microliters


370 microliters

-0.64%

≤|±3%|


Sample size5


1.03745 grams


1.40298 grams

365.530mg


0.9968 milligrams per microliter


366.70 microliters


370 microliters

-0.89%

≤|±3%|


Mean

 

 

365.202mg


0.9968 milligrams per microliter


366.37 microliters


370 microliters

-0.98%

≤|±3%|

CV

 

 

0.47%

 

0.47%

 

 

1.5%


Test times


Pre-tare weighing


Tare Weight


Actual annotation samples


Density


Annotated sample


Nominal value


Deviation


Standard requirements


Sample size1


1.04112 grams


1.53603 grams

494.910mg


0.9968 milligrams per microliter


496.50 microliters


500 microliters

-0.70%

≤|±3%|


Sample size2

1.05057g


1.54905 grams

498.480mg


0.9968 milligrams per microliter


500.08 microliters


500 microliters

0.02%

≤|±3%|


Sample size3


1.04238 grams


1.53901 grams

496.630mg


0.9968 milligrams per microliter


498.22 microliters


500 microliters

-0.36%

≤|±3%|


Sample size4


1.04193 grams


1.53883 grams


496.900 mg


0.9968 milligrams per microliter


498.50 microliters


500 microliters

-0.30%

≤|±3%|


Sample size5

1.03405g

1.53109g


497.040 mg


0.9968 milligrams per microliter


498.64 microliters


500 microliters

-0.27%

≤|±3%|


Mean

 

 

496.792mg


0.9968 milligrams per microliter


498.39 microliters


500 microliters

-0.32%

≤|±3%|

CV

 

 

0.26%

 

0.26%

 

 

1.5%