English Product Name

Overview

The HXC-158 Blood Refrigerator is a purpose-built, upright medical-grade refrigeration system engineered specifically for the safe, stable, and compliant storage of whole blood, packed red blood cells (RBCs), platelet concentrates (when held at 20–24 °C in alternate configurations), 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 clinical requirements defined in AABB Standards for Blood Banks and Transfusion Services, this unit employs forced-air circulation and precision microprocessor-based temperature control to ensure uniform thermal distribution across the entire storage chamber—critical for preventing localized temperature excursions that may compromise hemoglobin integrity or increase bacterial proliferation risk. Its ST-class climate rating (suitable for ambient temperatures up to 32 °C) and anti-condensation heated glass door enable reliable operation in high-humidity clinical environments without compromising visibility or insulation performance.

Key Features

• Five independent alarm channels: High-temperature, low-temperature, power failure, door-open, sensor fault, and internal battery depletion—each triggering immediate notification via audible buzzer, visual LED indicators, and dry-contact remote alarm output (NO/NC configurable).
• Adjustable shelving architecture: Four-tier powder-coated wire shelves with 50 kg static load capacity per level; vertical spacing can be reconfigured to accommodate variable-height blood storage baskets or stacked plasma units.
• Medical-grade thermal insulation: High-density, non-ozone-depleting polyurethane foam (CFC/HCFC-free) with optimized thickness distribution ensures consistent thermal retention and meets EN 61000-6-3 EMC immunity standards.
• Robust compressor system: Internationally certified hermetic compressor, subjected to dual 85 °C / 85% relative humidity accelerated aging tests, delivering long-term reliability and reduced mean time between failures (MTBF) in continuous 24/7 operation.
• Human-centered interface: Password-protected LED display with 0.1 °C setpoint resolution, real-time temperature logging capability (optional USB data logger), and intuitive navigation for clinical staff with minimal technical training.

Sample Compatibility & Compliance

The HXC-158 is validated for storage of anticoagulated whole blood (CPD, CPDA-1, or additive solutions), leukoreduced RBC units, cryoprecipitate (post-thaw holding), and certain diagnostic reagents requiring strict +4 °C stabilization. Its stainless-steel interior (AISI 304) resists corrosion from saline-based solutions and facilitates routine disinfection using hospital-grade quaternary ammonium or hydrogen peroxide wipes. The unit complies with IEC 61010-1 (Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use) and carries CE marking per MDR 2017/745 Annex II Class IIa. It supports GLP/GMP-aligned workflows through optional audit-trail-enabled data loggers (USB interface), enabling traceability required under FDA 21 CFR Part 11 when paired with validated software platforms.

Software & Data Management

While the base HXC-158 operates as a standalone cabinet with embedded firmware, it supports integration into centralized cold chain monitoring systems via its dry-contact remote alarm port and optional USB-connected temperature recorder. The recorder captures timestamped temperature data at user-defined intervals (1–60 min), stores ≥30 days of history locally, and exports CSV files compatible with LIMS or electronic quality management systems (eQMS). All firmware updates are performed offline via secure USB key—no network connectivity required—to maintain air-gapped security in regulated laboratory environments.

Applications

This refrigerator serves critical roles in hospital blood banks, regional transfusion centers, clinical pathology labs, and biorepository core facilities. Typical use cases include: short-term storage of blood products prior to crossmatching and issuance; holding freshly collected donor samples pending serological testing; maintaining stability of calibration standards for coagulation analyzers; and supporting ISO 15189-accredited hematology workflows where documented temperature continuity is mandatory. Its compact footprint (0.56 m width) and castor-mounted chassis with locking leveling feet allow flexible deployment in space-constrained utility rooms or mobile blood collection units.

FAQ

What is the recommended ambient operating environment for the HXC-158?

The unit is rated ST-class and designed for stable operation at ambient temperatures between 10–32 °C and relative humidity up to 80% RH, with anti-condensation door heating active under those conditions.

Does the HXC-158 support temperature mapping validation?

Yes—the single external temperature probe access port (1 × Ø6 mm) allows insertion of calibrated thermocouples or data loggers for IQ/OQ/PQ qualification per ISO 14644-1 and EU GMP Annex 1 cold chain guidelines.

Can the alarm outputs interface with building management systems (BMS)?

The remote alarm terminal provides a potential-free, normally open (NO) contact signal compatible with most BMS input modules for centralized alerting and incident logging.

Is the internal lighting compliant with photostability requirements for blood products?

The LED interior lamp emits no UV radiation and features low-intensity, cool-white illumination (≤3000 K CCT) to minimize photo-oxidative degradation of hemoglobin and labile coagulation factors.

What documentation is provided for regulatory submission?

Standard delivery includes Declaration of Conformity (CE), NMPA Medical Device Registration Certificate (China), factory calibration report, user manual, and electrical safety test summary—available in English upon request.