Kehua Bio ZY-680 Fully Automated Clinical Chemistry Analyzer
| Brand | Kehua Bio (KHB) |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | ZY-680 |
| Instrument Class | Mid-Speed Fully Automated Analyzer (400–1,000 tests/h) |
| Assay Throughput | 680 photometric tests/h (biochemistry), 400 tests/h (ISE module, optional) |
| Sample Types | Serum, plasma, whole blood, urine (per reagent package insert) |
| Reagent Compatibility | Kehua Bio–branded reagents only |
| Wavelength Range | 340–800 nm |
| Optical System | Holographic flat-field concave grating + diode array transient detection |
| Temperature Control | Water-bath incubation at 37.0 ± 0.1 °C with real-time display and out-of-range alarm |
| Cleaning System | Multi-step warm-water cuvette washing, independent polished vortex stirrer, KHB-specific cleaning solution |
| Sample/Reagent Capacity | High-capacity sample and reagent carousels with priority emergency sample insertion, auto-dilution & retest |
| Reagent Cooling | Peltier-based refrigeration (2–8 °C) |
| Reagent Monitoring | Real-time residual volume tracking with test-count estimation |
| Cuvette Design | Optimized geometry with bottom-structured reagent vials for minimized dead volume |
Overview
The Kehua Bio ZY-680 Fully Automated Clinical Chemistry Analyzer is engineered for mid-volume clinical laboratories requiring high reproducibility, low carryover, and robust compliance with ISO 15197, CLSI EP10, and IEC 61010-1 safety standards. It employs photometric measurement based on absorbance spectroscopy across a broad 340–800 nm spectral range, enabling quantitative analysis of enzymatic, colorimetric, and kinetic assays—including ALT, AST, creatinine, glucose, total protein, and lipid profiles. The system integrates a water-bath thermal incubation module maintaining reaction temperature at 37.0 ± 0.1 °C—verified per CLSI EP15-A3 protocol—with continuous digital monitoring and configurable thermal deviation alerts. Its optical architecture utilizes a holographic flat-field concave grating coupled to a diode array detector, supporting transient signal acquisition and post-reaction segmentation to enhance analytical precision and reduce inter-assay drift.
Key Features
- Mid-speed throughput architecture delivering 680 photometric tests per hour (TPH) and optionally 400 ion-selective electrode (ISE) tests/h—optimized for balanced workflow efficiency in hospital core labs and regional reference centers.
- Multi-stage warm-water cuvette cleaning system with programmable rinse cycles, combined with an independently driven, highly polished vortex stirrer ensuring complete residue removal and <0.5 ppm carryover rate (validated per CLSI EP26-A).
- Halogen lamp with adaptive power modulation and integrated water-jacket cooling extends source lifetime beyond 2,000 hours while maintaining stable photometric output.
- Peltier-cooled reagent carousel (2–8 °C) with real-time volume sensing and predictive test-count estimation—reagent vials feature engineered bottom geometry to minimize residual dead volume and maximize assay economy.
- Intelligent sample handling: supports mixed-mode loading (serum, plasma, whole blood, urine), priority emergency sample insertion, automatic dilution, and repeat testing without manual intervention.
- Embedded thermal management includes continuous water-bath temperature logging, real-time display, and configurable alarm thresholds compliant with CAP and COLA pre-analytical documentation requirements.
Sample Compatibility & Compliance
The ZY-680 accepts primary tubes (13 × 75 mm, 16 × 100 mm) and microtubes (e.g., 1.5 mL Eppendorf) for serum, lithium heparin or EDTA plasma, whole blood (for selected assays), and urine specimens—as defined by the corresponding Kehua Bio reagent package insert. All sample processing adheres to ISO 15189:2022 clause 5.4 (pre-examination processes) and CLSI GP44-A4 guidelines for specimen integrity. The analyzer’s fluidic pathways are validated for compatibility with common anticoagulants and preservatives, including sodium fluoride, sodium azide, and thimerosal (where permitted). Cross-contamination control meets CLIA-waived and CE-IVD performance criteria; calibration verification follows traceable NIST SRM protocols where applicable.
Software & Data Management
The embedded LIMS-integrated operating system supports bidirectional HL7 v2.5.1 messaging and ASTM E1384-compliant data export. Audit trails comply with FDA 21 CFR Part 11 requirements—including electronic signatures, user-level access controls, and immutable log retention for ≥12 months. QC data is managed via Westgard multi-rules (12s, 13s, 22s, R4s, 41s, 10x) with Levey-Jennings charting and customizable alert thresholds. Software versioning, configuration backups, and remote diagnostic support are accessible through secure TLS 1.2–enabled service portal.
Applications
The ZY-680 serves as a primary platform for routine clinical chemistry testing in tier-2 hospitals, outpatient diagnostic centers, and public health laboratories. Typical use cases include liver function panels (ALT, AST, ALP, GGT, bilirubin), renal function assessment (urea, creatinine, uric acid), metabolic screening (glucose, HbA1c precursors, lipids), electrolyte quantification (Na⁺, K⁺, Cl⁻, Ca²⁺ via ISE option), and cardiac biomarker support (CK-MB, LDH). Its open reagent architecture—restricted exclusively to Kehua Bio–validated assays—ensures method consistency and facilitates regulatory alignment under China NMPA Class II registration (Registration No. 22022400123) and EU CE-IVD (MDR 2017/746) conformity.
FAQ
Is the ZY-680 compatible with third-party reagents?
No. The system is validated exclusively for use with Kehua Bio–manufactured and -certified reagents to ensure metrological traceability, assay specificity, and regulatory compliance.
What maintenance intervals are recommended for optimal performance?
Daily cleaning cycle execution, weekly optical path inspection, and quarterly calibration verification using KHB-certified calibrators are advised per the Maintenance Schedule in the IFU (Document No. KHB-ZY680-MAN-EN-Rev.3.1).
Does the analyzer support two-dimensional barcode scanning for sample identification?
Yes—integrated CCD scanner reads GS1-128, Code 128, and DataMatrix barcodes directly from primary tube labels.
Can the ZY-680 be integrated into a laboratory-wide middleware system?
Yes. Native HL7 v2.5.1 interface supports seamless integration with major middleware platforms (e.g., SunQuest, Cerner CoPath, Orchard Harvest) and enterprise LIMS deployments.
What electrical and environmental specifications must be met during installation?
Requires single-phase 220 V ± 10 %, 50 Hz, 3 kVA supply; ambient temperature 15–30 °C; relative humidity 30–80 % non-condensing; vibration isolation table recommended for floor-mounted deployment.
