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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:AC100～240V;

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 P_v≤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	Aftertheprototypestructureappearance、temperaturecontrol、sampleadditionperformanceandfunctionallmeetthetechnicalrequirements。	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.

③ 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
Module Number		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
Module Number		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:

① 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.

② 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 = ( Tf_max - Tf_min ) / 2………………………………（2）

Where:

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

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

Tf_min ------ 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℃,30℃and30℃/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 V_R, 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 = $\frac{M_{2} − M_{1}}{ρ_{去离子水}}$ ………………………………………（2）

P_v = $| \frac{V_{i} − V_{R}}{V_{R}} | ×100%$ ……………………………（3）

Where:

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

V_R ----------------Control amount；

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

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

ρ_{deionized water}------------Density of deionized water (measured using a hydrometer);

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

2.3.3.3 Judgment Criteria

Reagent addition volumes at 100μL, 130μL, 240μL, 370μL, 500μL control points require: P_vdeviation ≤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 waterρ_{deionized 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, 370μL、500μL. Compare the mass of the centrifuge tubes before and after adding liquid, and repeat the measurement 5 times.

(2)Let the control volume be V_R, 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 V_STDof the actual sample volume according to formula (5), and calculate the coefficient of variation CV according to formula (6).

Related Calculation Formulas:

V_A_VE = $\frac{V_{1} + V_{2} + V_{3} + V_{4} + V_{5}}{5}$ ………………………（4）

V_std = $\sqrt{\frac{1}{n−1} \sum_{i=1}^{n} {(V − V_{AVE})}^{2}}$ …………………（5）

CV = $\frac{V_{STD}}{V_{AVE}} × 100%$ ……………………………（6）

Where:

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

V_A_VE --------------Average actual sample volume;

V_STD --------------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: CV≤5%.

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℃、85℃and 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%