I. Purpose

Used for automatic measurement of inhibition zones, antibiotic potency analysis, etc.

II. Main Technical Specifications

1. Equipped with an A4-format color CCD dual-light source scanning imager (adjustable brightness, auto-focus), capable of achieving optical resolution of 40 million pixels with floating dark-field imaging. Features automatic enhancement imaging for inhibition zones.

2. Compatible with petri dishes: 50–180 mm and rectangular plates within A4 format; can simultaneously measure 6 petri dishes of 90 mm.

3. ★One-click fully automatic measurement of all inhibition zones in 1–6 petri dishes of 90 mm diameter. Capable of fully automatic measurement of partially adherent inhibition zones, automatically obtaining results such as inhibition zone area and diameter even with partial text interference. Can uniformly save or review various types of analysis data. Meets the requirements of all detection indicators in "JJF1614-2017 Calibration Specification for Antibiotic Potency Analyzers." Optional use of standard templates calibrated by legal metrology institutions for periodic instrument calibration.

4. ★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. Measurement accuracy error for a 360° rotation with standard template ≤±0.05 mm; indication accuracy error with standard template ≤±0.05 mm; repeat measurement error ≤±0.01 mm; potency measurement accuracy error ≤±0.3%; inter-instrument measurement error ≤±0.3%.

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

6. Measurement functions: fully automatic size calibration, with manual calibration option. Allows precise measurement of length, angle, arc, area, arc curves, and arbitrary curves via mouse drag.

7. ★Data traceability and permission protection; operational records can be tracked and traced, complying with GLP and GMP requirements. Utilizes a multi-level system architecture with assigned functions and permissions to ensure data security, integrity, and authenticity. Features three-level hierarchical permission management:

(1) System Administrator: Responsible for creating and managing all general administrator and operator accounts, setting permissions for general administrators and operators. There is only one system administrator with the highest system privileges. The system includes enhanced password strength requirements and account disablement functions.

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

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

(5) The system automatically records the operational history of each account. The system administrator can trace, review, and output these records. Features export and import of inhibition zone setting parameters, as well as automatic data saving.

III. Standard Configuration

1. HiCC-F Fully Automatic Inhibition Zone Measuring System Software USB drive and software lock (1 set)

2. A4-format high-resolution color CCD dual-light source scanning imager (1 unit)

Remarks:

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

2. This product requires a computer. Recommended brand computer (12th Gen or higher Core i5 CPU / 16GB RAM / 21.5" color display / wireless network card, 1 USB 3.0 port + 3 USB 2.0 ports, operating environment: Windows 7, Windows 10, Windows 11).

3. Optional HiCC series automatic inhibition zone measuring instrument dedicated standard plate (with one authoritative calibration certificate) (1 unit)

4. 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.