CZGY GYXW-X Digital Constant-Temperature Platelet Agitator and Storage Incubator

Overview

The CZGY GYXW-X Digital Constant-Temperature Platelet Agitator and Storage Incubator is a purpose-built medical device engineered for the compliant, uninterrupted storage and agitation of platelet concentrates under AABB, CLSI, and ISO 22367:2021–compliant conditions. It operates on the principle of horizontal reciprocating motion combined with precise air-jacketed thermal regulation to maintain platelets within the critical 20–24 °C range—ensuring metabolic viability, membrane integrity, and functional readiness for transfusion. Unlike general-purpose shakers, the GYXW-X integrates biomedical-grade thermal stability, fail-safe monitoring, and sterile handling features specifically validated for blood bank workflows. Its design conforms to ISO 13485 quality management requirements for in vitro diagnostic (IVD) support equipment and supports traceability under GLP/GMP-aligned documentation practices.

Key Features

• Brushless DC motor drive delivering stable 60 rpm oscillation with ±0.5 rpm repeatability over continuous 72+ hour operation—eliminating carbon wear, electromagnetic interference, and torque drift common in brushed motors.
• Fuzzy PID temperature controller with segment LCD interface enables real-time setpoint adjustment and maintains chamber uniformity within ±0.8 °C across all shelf levels (validated per ISO 17025 calibration protocol).
• Dual-layer vacuum-insulated tempered glass door provides high thermal resistance (U-value ≤0.8 W/m²·K), minimizes condensation, and allows visual verification of platelet bag orientation without opening the chamber.
• 10/15/20-tier configurable stainless steel shelving system (AISI 304, electropolished finish) optimized for standard platelet storage bags (up to 400 mL); each shelf features non-slip rubberized edge retention and independent airflow channeling.
• Integrated UV-C germicidal lamp (254 nm, 15 W) with manual activation and auto-shutoff interlock ensures periodic decontamination of internal surfaces between cycles—validated against ISO 15883-1 for reprocessing of medical devices.
• Multi-level safety architecture includes dual independent temperature sensors, audible/visual high-low threshold alarms (24 °C), and automatic power cutoff upon door-open detection or thermal runaway.

Sample Compatibility & Compliance

The GYXW-X accommodates standard platelet units stored in PVC, polyolefin, or ethylene vinyl acetate (EVA) blood bags. Its horizontal reciprocating motion (50 mm amplitude, 60 rpm) replicates clinically validated agitation profiles defined in AABB Technical Manual (21st ed.) Section 12.2 and CLSI GP45-A4. The chamber’s air-based heat transfer mechanism avoids direct contact heating, preventing localized thermal stress on bag welds or plasticizers. All materials in contact with the storage environment meet USP Class VI biocompatibility standards. Device validation documentation—including temperature mapping reports (per ISO 14644-3), agitation uniformity verification, and alarm response testing—is provided upon request to support regulatory audits (FDA 21 CFR Part 11, EU MDR Annex I, and China NMPA Class II registration pathways).

Software & Data Management

While the GYXW-X operates via embedded hardware controls, it supports external data logging through optional RS-485 or USB-to-serial interface (available as OEM add-on). Integrated real-time temperature recording can be printed via built-in thermal printer (optional), generating time-stamped logs compliant with CAP checklist TRM.42320 and AABB Standard 5.12.1 for platelet storage documentation. Audit trail functionality—including operator ID, parameter changes, alarm events, and door-open duration—is retained in non-volatile memory for ≥30 days. Data export formats include CSV and PDF for integration into LIS/HIS platforms or electronic blood bank management systems (e.g., BloodTrack, Haemonetics SafeTrace TX).

Applications

• Continuous 22 °C ±2 °C agitation and storage of platelet concentrates during pre-transfusion holding periods (up to 5 days per FDA 21 CFR 640.22).
• Supporting automated blood component processing lines where platelet units require intermediate staging prior to pooling, pathogen reduction, or leukoreduction.
• Use in clinical transfusion services, regional blood centers, hospital blood banks, and Good Manufacturing Practice (GMP)-compliant plasma derivative manufacturing facilities.
• Research applications involving platelet function assays requiring standardized agitation history prior to flow cytometry, aggregometry, or thromboelastography (TEG/ROTEM).

FAQ

What is the maximum allowable deviation from setpoint during extended operation?
The unit maintains ≤±0.8 °C spatial uniformity across all shelf positions when loaded with 20 standard platelet bags, verified per ISO 17025-accredited temperature mapping.
Can the oscillation frequency be adjusted?
No—the 60 rpm setting is fixed to comply with AABB-recommended agitation parameters for platelet viability; variable-speed operation is not supported.
Is the UV sterilization cycle validated for microbial reduction?
Yes—log₃ reduction of Staphylococcus aureus and Escherichia coli is achieved after 30 minutes of exposure at 1.0 m distance, per ISO 15883-1 Annex D.
Does the device support remote monitoring or network connectivity?
Standard configuration includes local display and thermal printout only; Ethernet or Wi-Fi modules are available under custom OEM agreement with additional validation support.
How often does the temperature sensor require recalibration?
Annual recalibration is recommended using NIST-traceable dry-block calibrators; calibration certificates and SOP templates are supplied with the instrument.