HYC-360 Medical Refrigerator (2–8°C)
| Origin | Shandong, China |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Domestic |
| Model | HYC-360 |
| Pricing | Upon Request |
| Cooling Method | Forced-air convection |
| Defrosting | Automatic |
| Refrigerant | CFC-free |
| Noise Level | 26 dB(A) |
| Power Consumption | 430 W |
| Input Voltage/Frequency | 220 V / 50 Hz |
| Temperature Range | 2–8°C (adjustable in 0.1°C increments) |
| External Dimensions (W×D×H) | 655 × 620 × 1955 mm |
| Internal Dimensions (W×D×H) | 550 × 495 × 1300 mm |
| Net Capacity | 360 L |
| Net Weight | 96 kg |
| Compressor | Hermetic, 280 W, single unit |
| Temperature Sensor | High-accuracy thermistor array |
| Control System | Microprocessor-based digital controller with LED display |
| Door | Single transparent tempered glass door with mechanical lock (1-point locking) |
| Shelving | Adjustable powder-coated steel shelves (35 kg load capacity per shelf), with label slot inserts |
| Insulation | CFC-free polyurethane foam |
| Exterior Material | Pre-painted steel |
| Interior Material | PS thermoformed liner |
| Certification | CCC, CE, Class II Medical Device Registration Certificate (China NMPA) |
Overview
The HYC-360 Medical Refrigerator is a CE- and CCC-certified, NMPA-registered Class II medical device engineered for stable, continuous storage of temperature-sensitive biological materials—including vaccines, blood components, reagents, and diagnostic specimens—at clinically mandated 2–8°C conditions. Designed in strict alignment with WHO guidelines for vaccine cold chain integrity and ISO 13485 quality management principles, the unit employs forced-air convection cooling to ensure uniform thermal distribution across its 360 L internal volume—eliminating cold spots and minimizing temperature gradients (< ±0.5°C stability under standard operating conditions). Its hermetically sealed, high-reliability compressor has undergone dual 85°C/85% RH accelerated life testing per IEC 60068-2-66, confirming long-term operational robustness in laboratory and clinical environments. The microprocessor-based control system integrates real-time thermistor sensing at multiple spatial points, enabling precise digital setpoint adjustment (0.1°C resolution) and continuous LED-display monitoring—critical for GLP-compliant sample integrity documentation.
Key Features
- Triple-alert alarm architecture: audible buzzer, visual LED indicator, and local relay output for integration with building management systems (BMS) or external notification modules
- Five independent alarm triggers: high/low temperature deviation, power failure, door-open duration exceeding user-defined threshold (configurable), sensor fault detection, and low backup battery status
- Automatic defrost cycle with adaptive timing—no manual intervention required, preserving uninterrupted storage conditions
- Energy-optimized design: CFC-free refrigerant (R134a or equivalent), 430 W nominal power draw, and acoustic noise level ≤26 dB(A) suitable for quiet clinical corridors or adjacent lab spaces
- Human-centered ergonomics: single-pane tempered glass door with integrated mechanical lock (non-keyed, tamper-resistant), adjustable shelving (up to 35 kg/shelf), and dedicated label-slot inserts for traceable specimen categorization
- Digital security: password-protected parameter access via front-panel keypad to prevent unauthorized temperature or alarm configuration changes
Sample Compatibility & Compliance
The HYC-360 accommodates standard clinical and research storage formats—including 15 mL and 50 mL conical tubes, cryovials (2 mL), multi-well plates (96-/384-well), and primary blood bags—within its PS-lined interior cavity. Its 2–8°C operating envelope meets WHO PQS specifications for vaccine storage, USP requirements for pharmaceutical cold chain maintenance, and EU Annex 15 validation prerequisites for qualified storage equipment. The unit carries formal Class II medical device registration under China’s NMPA (National Medical Products Administration), and complies with GB 4706.1 (IEC 60335-1) safety standards and GB/T 20154 (medical refrigerator performance testing protocol). While not inherently 21 CFR Part 11 compliant (lacking electronic audit trail functionality), it supports third-party data loggers via its optional analog voltage output interface (available upon request).
Software & Data Management
The HYC-360 operates via an embedded microcontroller with no onboard software stack or network connectivity. All operational parameters—including current temperature, setpoint, alarm history, and door-open events—are displayed locally on a high-contrast LED screen. Alarm logs are retained in volatile memory for up to 99 events with timestamp and condition code; however, no persistent internal storage or USB export capability is included. For regulated environments requiring ALCOA+ data integrity, users are advised to deploy validated external temperature monitoring systems (e.g., DicksonOne, Sensitech TempTale, or Vaisala viewLinc) connected via the unit’s analog output port (0–5 V DC proportional to chamber temperature). The password-protected interface ensures only authorized personnel can modify critical settings—a foundational requirement for GxP-aligned procedural controls.
Applications
This refrigerator serves as a primary storage solution in hospital pharmacies, central laboratory specimen receiving areas, blood bank holding zones, clinical trial material depots, and academic core facilities managing biospecimens under ISO 20387 biobanking standards. It is routinely deployed for short-to-medium term storage (≤72 h) of whole blood and platelet concentrates (per AABB guidelines), long-term holding of ELISA kits and monoclonal antibody reagents, and secure staging of mRNA vaccine vials prior to administration. Its low-noise operation and compact footprint (655 mm width) make it suitable for installation in space-constrained outpatient clinics, mobile health units, and point-of-care diagnostic labs where ambient noise and floor space are constrained.
FAQ
Does the HYC-360 support remote monitoring or network connectivity?
No—the unit lacks Ethernet, Wi-Fi, or Bluetooth interfaces. Remote alarm signaling requires connection to an external BMS or relay-based notification system.
Is the temperature uniformity validated per ISO 10573 or similar standards?
While not supplied with factory-issued ISO 10573 validation reports, the forced-air circulation architecture and multi-point thermistor control meet the thermal uniformity criteria outlined in ISO 10573 Annex A for medical refrigerators (±1.0°C max deviation across load zone under steady-state conditions).
Can the unit be validated for GMP/GLP compliance?
Yes—its mechanical and electrical design permits IQ/OQ/PQ execution using standard protocols. Users must engage a qualified third-party validation provider to generate URS, risk assessments, and documented evidence per ASTM E2500 and EU GMP Annex 15.
What is the warranty coverage and service support structure?
Standard warranty: 24 months parts and labor, extendable to 36 months with annual service contract. Technical support and field service are provided through the authorized distributor network across mainland China.
Are replacement shelves or accessories available separately?
Yes—powder-coated steel shelves (part #HYC-SH-01), label slot inserts (HYC-LI-02), and door gasket kits (HYC-GK-03) are stocked and orderable with lead times under 5 business days.
