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
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