HiCC-E Type β-Lactamase Analyzer System

I. Applications

Used for automatic inhibition zone measurement, β-lactamase testing and analysis, antibiotic susceptibility potency analysis, etc.

II. Main Technical Specifications

1. ★Imaging

(1) Equipped with an A4 extended-format color CCD scanner (adjustable brightness, auto-focus), capable of achieving 40-megapixel optical resolution with floating dark-field imaging.

(2) Compatible with petri dishes: 50–180 mm and rectangular plates within A4 size; can simultaneously measure 6 x 90 mm petri dishes.

2. ★Inhibition Zone Measurement

(1) One-click fully automatic measurement of all inhibition zones in 6 x 90 mm diameter petri dishes; capable of automatically measuring partially overlapping inhibition zones; can automatically obtain results such as inhibition zone area and diameter even with partial text interference. Allows unified saving or viewing of various types of analytical data.

(2) True-to-life visual comparison and editing functions. The inhibition zone measurement system has a reading resolution ≤ 0.001 mm; simultaneous analysis of 6 petri dishes takes ≤ 8 seconds; rotational measurement accuracy error (360° based on standard template) ≤ ±0.05 mm; indication accuracy error (based on standard template) ≤ ±0.05 mm; repeat measurement error ≤ ±0.01 mm; potency measurement accuracy error ≤ ±0.3%; inter-instrument measurement error ≤ ±0.3%.

3. ★Sulbactam-Sensitive β-Lactamase Testing

(1) Based on the National Health Commission's "Method for Testing Sulbactam-Sensitive β-Lactamase Substances in Milk and Dairy Products—Cylinder Plate Method," measures sulbactam-sensitive β-lactamase (e.g., Jin Yulan enzyme) substances in milk and dairy products. Automatically determines the validity of analytical results for 6 petri dishes based on inhibition zone diameters from pure water control tubes (A), (B), and (D). Automatically generates positive or negative result reports based on inhibition zone diameters from sample tubes (A) and (B).

(2) Automatically excludes impurities or abnormal defects based on size differences, making reports more comprehensive and reliable. Can generate reports compliant with GLP/GMP requirements, adhering to the integrity of original data and records, providing comprehensive data support for laboratory certification. Historical data can be retrieved arbitrarily, facilitating digital document management in the laboratory.

4. ★Antibiotic Susceptibility Potency Analysis

(1) Petri dishes can be placed in any orientation. Features automatic selection of inhibition zone samples, true-to-life visual comparison, and editing functions. The inhibition zone measurement system has a reading resolution ≤ 0.001 mm; simultaneous analysis of 6 petri dishes takes ≤ 8 seconds; rotational measurement accuracy error (360° based on standard template) ≤ ±0.05 mm; indication accuracy error (based on standard template) ≤ ±0.05 mm; repeat measurement error ≤ ±0.01 mm; potency measurement accuracy error ≤ ±0.3%; inter-instrument measurement error ≤ ±0.3%.

(2) Complies with Chinese Pharmacopoeia, USP (United States Pharmacopeia), EP (European Pharmacopoeia), and British Pharmacopoeia. Capable of performing the latest national pharmacopoeia (2020 edition) one-, two-, and three-dose analyses and combined calculations, as well as antibiotic potency analysis for all bacterial strains. Features combinatorial optimization analysis for potency.

(3) Built-in all data from the latest CLSI (Clinical and Laboratory Standards Institute) "Performance Standards for Antimicrobial Susceptibility Testing" 25th edition (2015), providing a data input and modification platform for easy updates, offering a quick tool for disk diffusion susceptibility analysis.

(4) According to the food additive nisin standard QB 2394-2007, can automatically measure over 24 inhibition zones on extra-large rectangular plates in one go and automatically analyze potency. Customizable sample dropping schemes based on user requirements.

5. Measurement Functions: Fully automatic size calibration, also allows manual calibration. Precise measurement of length, angle,弧度, area, arc, and arbitrary curves via mouse drag.

6. Data Export: Analysis results can be saved and automatically generated into Excel or PDF report documents. The software supports online upgrades.

7. ★Data Traceability and Permission Protection; operational records are traceable and reviewable, compliant with GLP and GMP requirements, ensuring data security, integrity, and authenticity.

(1) System Administrator: Responsible for creating and managing all accounts for general administrators and operators, setting permissions for general administrators and operators. There is only one system administrator with the highest system privileges.

(2) General Administrator: Responsible for reviewing all test data, managing archives, and other system data management. Multiple general administrators can be assigned; their permissions are set and allocated by the system administrator.

(3) Operator: Responsible for sample preparation, testing, corrections, generating electronic reports, submitting for review, etc. Multiple operators can be assigned; their permissions are set and allocated by the system administrator.

(4) All accounts can modify their own login passwords and set their electronic signatures to be output in reports.

(5) The system automatically records operational logs for each account. The system administrator can trace, review, and export these operational records.

III. Standard Configuration

1. HiCC-E Type β-Lactamase Testing Analyzer System Software USB drive and software lock: 1 set

2. A4 Extended-format color CCD scanner: 1 unit

Remarks:

1. Items marked with ★ in this technical specification must be complied with; otherwise, it will be considered a major deviation.

2. This product requires a computer. Recommended optional: branded computer (12th Gen or higher Core i5 CPU / 16GB RAM / 21.5" color display / wireless network card, 1 x USB 3.0 + 3 x USB 2.0 ports, running Windows 10 full Professional or Ultimate edition).

3. Optional: Oxford cup placement plate (4-well plate for two-dose, 6-well plate for three-dose), suitable for 90 mm petri dishes and 7.8 mm Oxford cups compliant with the new pharmacopoeia.