HYC-940 Medical Refrigerator (2–8°C), Vertical Upright Laboratory Cold Storage Unit
| Origin | Shandong, China |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Domestic (China) |
| Model | HYC-940 |
| Pricing | Available Upon Request |
Overview
The HYC-940 Medical Refrigerator is a CE-compliant, Class IIa medical device (registered under China NMPA as a Class II medical instrument) engineered for precise, stable, and compliant cold-chain storage of temperature-sensitive biological materials in clinical laboratories, pharmacies, blood banks, and GMP-regulated biopharma environments. Operating within a tightly controlled 2–8°C range—aligned with WHO, USP , and EU GDP guidelines for refrigerated pharmaceuticals and diagnostic reagents—the unit employs forced-air convection cooling to ensure uniform temperature distribution (±0.5°C stability, typical across all zones per IEC 61000-4-2 validation protocols). Its microprocessor-based digital temperature controller integrates high-accuracy NTC thermistors at multiple internal locations, enabling real-time multi-point monitoring and dynamic thermal compensation. The cabinet’s structural integrity, insulation performance (35 mm CFC-free polyurethane foam), and energy-efficient design meet ISO 13485 quality system requirements for medical device storage infrastructure.
Key Features
- Five independent alarm functions: High/low temperature deviation, power failure, door-open duration (>30 sec), sensor fault, and low backup battery voltage—each triggering visual LED alerts, audible buzzer, and remote dry-contact output (NO/NC)
- Intelligent auto-defrost cycle activated by evaporator frost accumulation sensors—eliminates manual defrosting and prevents thermal shock to stored samples
- Adjustable powder-coated steel shelving system: Four removable, load-rated shelves (35 kg capacity each), height-adjustable in 25 mm increments, compatible with standard specimen racks and vaccine trays
- Dual-pane tempered glass doors with magnetic gasket seals and dual mechanical lock points (integrated key locks, no external padlock provision)—ensuring physical access control and minimizing heat ingress
- Low-noise operation (≤42 dB(A) at 1 m), energy-efficient 640 W hermetic compressor, and 900 W nominal input power—certified to GB 4706.1 and CCC safety standards
- LED digital display with 0.1°C resolution, password-protected parameter settings, and data logging capability via optional RS485 interface (Modbus RTU protocol)
Sample Compatibility & Compliance
The HYC-940 supports storage of vaccines (e.g., mRNA, viral vector, and protein subunit formulations), whole blood units, platelet concentrates, monoclonal antibodies, ELISA kits, PCR master mixes, and clinical trial reference standards. Its interior chamber (1025 × 590 × 1260 mm) provides 890 L net volume with non-corrosive electrogalvanized steel lining and rounded corners for easy decontamination. The unit complies with YY/T 0086–2018 (Chinese standard for medical refrigerators), IEC 61010-1 (safety of laboratory equipment), and carries mandatory CCC certification. Optional CO₂ or liquid nitrogen backup systems can be integrated for extended outage resilience—supporting continuity-of-care requirements per ISO 22301 business continuity frameworks.
Software & Data Management
While the base HYC-940 operates via embedded firmware without cloud connectivity, its RS485 port enables integration into centralized environmental monitoring systems (EMS) compliant with FDA 21 CFR Part 11 and Annex 11 (EU GMP). Temperature logs—including timestamps, setpoints, deviations, and alarm events—are retained locally for ≥30 days. When connected to validated third-party EMS platforms (e.g., SensiML, TempTale, or custom SCADA), it supports audit-trail generation, electronic signatures, and automated report exports (CSV/PDF). All configuration changes are logged with user ID and timestamp—fulfilling ALCOA+ data integrity principles.
Applications
- Clinical laboratory specimen refrigeration (serum, plasma, CSF, urine) prior to analysis
- Pharmacy cold-chain management for compounded sterile preparations (CSPs) and investigational medicinal products (IMPs)
- Blood bank component storage (RBCs, FFP, cryoprecipitate) under AABB-accredited conditions
- Vaccine inventory holding in national immunization programs requiring WHO PQ-certified storage integrity
- Biobank sample staging prior to cryo-transfer to −80°C or LN₂ freezers
- QC/QA release testing environments where ISO/IEC 17025 traceability mandates documented thermal stability
FAQ
What regulatory certifications does the HYC-940 hold?
It holds China NMPA Class II medical device registration, CCC safety certification, and compliance with YY/T 0086–2018 and GB/T 28039–2011 standards.
Is remote temperature monitoring supported out of the box?
Yes—via built-in dry-contact alarm outputs and optional RS485 Modbus RTU interface for integration with existing BMS or EMS platforms.
Can the unit maintain 2–8°C during a 30-minute power outage?
With standard configuration, thermal mass and insulation sustain safe temperature for ~22 minutes (tested per ICH Q5C); optional battery-backed alarm module extends notification window but does not power refrigeration.
Are calibration certificates provided with the unit?
Factory calibration reports (traceable to CNAS-accredited labs) are included; on-site IQ/OQ validation support is available through authorized service partners.
What is the recommended maintenance schedule?
Compressor oil inspection every 24 months; condenser coil cleaning every 6 months; door gasket integrity check quarterly—per manufacturer’s preventive maintenance protocol (SOP-MR-007).
