HXC-106 Blood Refrigerator – 4°C Precision Medical Storage Cabinet for Blood Bank Applications

Overview

The HXC-106 Blood Refrigerator is a CE-compliant, NMPA-registered medical-grade refrigeration system engineered exclusively for the safe, stable, and traceable storage of whole blood, packed red blood cells (RBCs), platelet concentrates, and other temperature-sensitive biological specimens requiring maintenance at +4 °C ± 2 °C. Designed in accordance with ISO 13485 quality management principles and aligned with WHO Guidelines for Blood Bank Refrigerators (2021), this upright cabinet employs forced-air circulation and precision microprocessor control to ensure uniform temperature distribution across the entire 106 L storage volume—critical for preventing thermal stratification that may compromise hematological integrity. Its refrigeration architecture integrates a hermetically sealed, internationally certified compressor validated under dual 85°C/85% RH environmental stress testing, delivering long-term operational stability and reduced mean time between failures (MTBF). The unit meets climate class N (18–32 °C ambient operating range) per IEC 60068-2-1/2, ensuring consistent performance in typical hospital utility rooms and blood bank environments.

Key Features

• Five-tiered alarm architecture: real-time monitoring of temperature deviation, power interruption, door status, sensor integrity, and internal backup battery level—each triggering simultaneous audible (buzzer), visual (LED indicator), and remote dry-contact outputs for integration into facility-wide BMS or alarm relay systems.
• Anti-condensation heated glass door: electrically heated tempered glass prevents surface moisture accumulation even at 32 °C ambient and 80% relative humidity—eliminating fogging during frequent access and preserving visibility of stored units without compromising thermal efficiency.
• Fully adjustable shelving system: powder-coated wire shelves support up to 50 kg each and slide vertically on stainless steel guides; spacing can be customized to accommodate variable-height blood storage baskets (standard 400 mL bag configuration supports up to 54 units), optimizing volumetric utilization while maintaining unobstructed airflow.
• Medical-grade interior construction: AISI 304 stainless steel chamber walls and floor resist corrosion from saline solutions, disinfectants, and repeated cleaning cycles; seamless welds minimize microbial harborage points in compliance with HTM 01-05 (UK) and AABB Standard 5.3.1.2.
• Energy-optimized design: CFC/HCFC-free refrigerant (R134a or equivalent), high-efficiency condenser coil, and intelligent fan-speed modulation reduce average power draw to 390 W while maintaining noise levels below 45 dB(A)—suitable for placement in staff-accessible corridors or adjacent to hematology labs.

Sample Compatibility & Compliance

The HXC-106 is validated for continuous storage of anticoagulated human blood products per AABB Standards for Blood Banks (2023 Edition), including CPD-, CP2D-, and AS-1/AS-3/AS-5 additive solutions. Its temperature uniformity profile (±0.8 °C max deviation across all nine test points per ISO 14644-3 methodology) satisfies CLSI GP35-A5 requirements for refrigerated blood storage. The cabinet carries an active Class II medical device registration certificate issued by China’s National Medical Products Administration (NMPA), and its electrical safety conforms to GB 4793.1–2007 (equivalent to IEC 61010-1). While not FDA 510(k)-cleared, its design basis aligns with USP environmental control expectations for sterile compounding support areas and supports GLP-compliant temperature mapping protocols via optional USB data logger integration.

Software & Data Management

Temperature logging is supported through optional external USB-connected chart recorders (sold separately), enabling export of time-stamped CSV files for audit trails and regulatory submissions. The onboard controller retains 30 days of min/max temperature history with timestamped event logs (e.g., door openings, alarm triggers, setpoint changes). Password protection (four-digit PIN) restricts access to calibration and alarm threshold adjustments—supporting role-based user permissions required under ISO 15189:2022 clause 5.3.2. No proprietary cloud platform is embedded; all data remains locally resident unless interfaced via dry-contact alarm relays to third-party building management systems (BMS) or centralized lab monitoring platforms compliant with HL7 or Modbus RTU protocols.

Applications

Primary deployment includes hospital blood banks, regional transfusion centers, clinical trial biorepositories handling fresh blood-derived samples, and reference laboratories performing hematologic assays requiring pre-analytical specimen stability. Secondary use cases encompass storage of reconstituted IV antibiotics (e.g., ceftriaxone, vancomycin), thawed plasma fractions, and temperature-labile enzyme reagents used in coagulation testing (PT/aPTT). The unit is not intended for cryopreservation, vaccine storage (which requires +2 to +8 °C tighter tolerances per WHO PQS), or long-term frozen tissue banking.

FAQ

Does the HXC-106 comply with AABB or CAP accreditation requirements for blood storage?
Yes—the cabinet’s temperature stability, alarm redundancy, and documentation capabilities meet AABB Standard 5.3.1.1 and CAP checklist GEN.40550 for refrigerated blood product storage.

Can the unit be integrated into a hospital’s central monitoring system?
Yes—via its configurable dry-contact alarm outputs (NO/NC), it interfaces directly with BMS or nurse call systems without requiring additional gateways.

Is temperature mapping validation supported out of the box?
The unit includes one calibrated thermistor sensor port (1 × 6 mm diameter detection hole) for third-party validation probes; users must perform initial IQ/OQ/PQ per ISO/IEC 17025 guidelines using external calibrated equipment.

What is the warranty coverage and service support structure?
Standard 24-month parts-and-labor warranty applies; field service is provided by authorized distributor-certified technicians trained under OEM technical bulletins.

Are replacement shelves and blood storage baskets available as spare parts?
Yes—stainless steel-dipped wire shelves (part #HXC-SH-01) and stackable 400 mL blood bag baskets (part #HXC-BK-04) are stocked and shipped globally within 5 business days.