SUNS SH300Z-5 Respiratory Circuit Tester

Overview

The SUNS SH300Z-5 Respiratory Circuit Tester is an engineered solution for functional verification and durability validation of medical respiratory circuits, anesthesia delivery systems, ventilator tubing assemblies, and associated pneumatic components. Designed in accordance with ISO 80601-2-12 (medical electrical equipment — particular requirements for basic safety and essential performance of critical care ventilators) and aligned with testing protocols referenced in ISO 10993-1 (biological evaluation of medical devices), the SH300Z-5 applies controlled pneumatic pressure to simulate clinical breathing cycles and assess structural integrity under repeated mechanical stress. Its core architecture implements closed-loop digital pressure control with dual-zone actuation—enabling independent regulation of upstream and downstream pressures within a single test sequence—to replicate asymmetric loading conditions observed during inspiratory/expiratory phase transitions. This capability supports both static leak integrity checks and dynamic life-cycle endurance tests up to thousands of cycles, with full traceability of pressure profiles, timing parameters, and pass/fail thresholds.

Key Features

• Five independent test channels, each configurable with unique pressure setpoints, cycle counts, dwell times, and ramp rates—no cross-channel interference or shared hardware dependencies.
• High-fidelity pressure control system delivering ±0.05% FS regulation accuracy and ±0.1% FS measurement repeatability across the full 0–800 kPa range, validated per ISO 9001 calibration traceability standards.
• Real-time, continuous pressure monitoring with automatic alerting on deviation exceeding user-defined tolerance bands—supports immediate intervention and prevents over-pressurization of sensitive components.
• Integrated 7-inch industrial-grade LCD touchscreen interface with intuitive navigation, password-protected parameter locking, and on-device test log review (last 1000 records).
• Dual-zone pressure actuation: separate solenoid-controlled regulators for inlet and outlet zones allow simulation of differential pressure gradients, mimicking physiological resistance during spontaneous breathing or pressure-support modes.
• Robust mechanical frame (1400 × 840 × 1600 mm) with reinforced mounting points for fixture integration; accommodates circuits up to 350 mm in length and standard ISO 5356-1 connector interfaces.

Sample Compatibility & Compliance

The SH300Z-5 accommodates a broad range of respiratory pathway configurations—including corrugated PVC tubing, heated wire circuits, bacterial/viral filters, humidification chambers, and Y-piece connectors—without requiring custom adapters. All wetted surfaces contacting test gas are constructed from FDA-compliant, non-reactive materials (316 stainless steel, PTFE-sealed valves, anodized aluminum manifolds). The instrument meets CE marking requirements under the EU Medical Device Regulation (MDR 2017/745) Annex I essential requirements for non-invasive equipment. It supports audit-ready documentation for GLP and GMP environments through timestamped, tamper-evident test reports compliant with FDA 21 CFR Part 11 when paired with validated data management software (see Software section).

Software & Data Management

A dedicated Windows-based PC application (compatible with Windows 10/11, 64-bit) enables remote configuration, real-time waveform visualization, and automated report generation in PDF or CSV format. The software logs all operational events—including channel activation, pressure transients, alarm triggers, and operator login sessions—with SHA-256 hash integrity verification. Audit trail functionality records user identity, timestamp, and action type for every parameter change, satisfying ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Optional RS485-to-Ethernet gateway support allows integration into centralized MES or LIMS platforms via Modbus TCP protocol.

Applications

• Validation of leak integrity for reusable and single-use breathing circuits prior to sterilization or clinical deployment.
• Accelerated life-cycle testing of pressure sensors, flow restrictors, and pop-off valves under cyclic load conditions simulating 5,000–50,000 breaths.
• Verification of compliance with ISO 8536-4 (infusion sets) and ISO 5367 (anesthesia breathing systems) pressure-holding requirements.
• Design verification testing for next-generation high-flow nasal cannula (HFNC) circuits and portable ventilator subsystems.
• Supplier qualification testing where objective, repeatable pneumatic performance metrics replace subjective manual inspection.

FAQ

What pneumatic supply specifications are required for stable operation?

Clean, oil-free, desiccated compressed air at 0.4–0.8 MPa supply pressure and ≤ -40°C dew point is mandatory. A coalescing filter (0.01 µm) and refrigerated dryer must be installed upstream.

Can the SH300Z-5 perform simultaneous multi-channel testing with different pressure profiles?

Yes—each of the five channels operates autonomously with independent pressure ramps, dwell periods, cycle counts, and pass/fail criteria defined per test plan.

Is the device suitable for ISO 13485-certified quality systems?

Yes—the instrument includes factory calibration certificates with NIST-traceable references, built-in self-diagnostics, and electronic record retention supporting design history file (DHF) and device master record (DMR) requirements.

How is firmware updated, and is version history retained?

Firmware updates are performed via USB stick using signed binary packages; previous three versions are archived internally with checksum verification and rollback capability.

Does the system support third-party SCADA integration?

Yes—Modbus RTU over RS485 and optional Modbus TCP via RJ45 enable direct integration with Siemens SIMATIC, Rockwell FactoryTalk, or Ignition SCADA platforms.