RWD R510-31 Medical Gas Source Unit for Anesthesia Systems
| Brand | RWD |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | R510-31 |
| Pricing | Upon Request |
Overview
The RWD R510-31 Medical Gas Source Unit is an engineered interface module designed to supply regulated, medically appropriate gas streams—either compressed medical-grade air or high-purity oxygen—to anesthesia delivery systems. It functions as a critical upstream component in veterinary and small-animal clinical anesthesia workflows, ensuring stable, contamination-controlled gas flow under variable demand conditions. The unit does not generate gas but serves as a configurable conduit and pressure-regulation interface between external gas sources (e.g., E-cylinder oxygen tanks or integrated air compressors) and the anesthesia machine’s gas inlet manifold. Its architecture complies with fundamental safety principles outlined in ISO 8573-1 (compressed air purity classes) and IEC 60601-1 (medical electrical equipment safety), with mechanical design optimized for integration into mobile or fixed-position anesthesia carts.
Key Features
- Dual-source configuration support: Selectable input for either medical oxygen (O₂ ≥ 99.5% purity per ISO 8573-1 Class 1) or compressed air (filtered to ISO 8573-1 Class 2 particulate and Class 3 moisture levels)
- E-cylinder compatibility: Designed for seamless integration with standard E-size oxygen cylinders (660 L nominal capacity at 2000 psi); includes mounting interface specifications for optional RWD E-cylinder bracket (sold separately)
- Integrated pressure regulation: Equipped with dual-stage stainless-steel diaphragm regulators delivering stable outlet pressure (0–0.4 MPa adjustable) with ±2% line regulation accuracy
- Flow monitoring readiness: Pre-configured ports for optional inline flow sensors (e.g., thermal mass flow meters) compliant with ASTM F1870-22 for anesthesia gas flow verification
- Material compliance: All wetted components constructed from 316L stainless steel or medical-grade acetal; non-leaching, non-reactive surfaces validated per USP and cytotoxicity testing
- Modular mounting: Standard 19-inch rack-mount flanges and M4 threaded inserts enable secure installation on RWD anesthesia workstations or third-party mobile carts
Sample Compatibility & Compliance
The R510-31 supports gas sourcing for RWD anesthesia machines used in rodent, rabbit, and canine models (body weight range: 20 g – 30 kg). It is compatible with both wall-supplied medical air/oxygen and portable cylinder-based systems. Regulatory alignment includes adherence to GB/T 16886.1 (biological evaluation of medical devices), YY/T 0786-2010 (anesthesia workstation standards), and general conformity with EU MDR Annex I essential requirements for ancillary gas supply units. While the unit itself is not CE-marked as an active therapeutic device, it meets supporting equipment criteria under EN ISO 13485:2016 quality management system requirements for manufacturers of medical device accessories.
Software & Data Management
As a passive mechanical gas interface, the R510-31 does not incorporate embedded firmware, wireless connectivity, or digital control logic. It operates without software dependency, eliminating cybersecurity concerns and ensuring deterministic performance across all operating environments—including electromagnetic-intensive OR settings. Documentation includes full traceability of material certifications (mill test reports for 316L SS), regulator calibration certificates (NIST-traceable), and assembly validation records aligned with GLP audit expectations. For facilities requiring electronic recordkeeping, RWD provides optional PDF-based logbooks compliant with FDA 21 CFR Part 11 signature and retention guidelines for manual entry of cylinder change events and pressure verification checks.
Applications
- Veterinary surgical suites requiring flexible gas sourcing for multi-species anesthesia protocols
- Academic research laboratories conducting longitudinal inhalational anesthetic studies where gas source switching (O₂ vs. air) must be reproducible across experimental arms
- Mobile field anesthesia units deployed in large-animal ambulatory care, where E-cylinder portability and rapid setup are operationally critical
- GMP-compliant preclinical CMC studies where documented gas source integrity (e.g., oxygen purity logs, air filter replacement schedules) supports regulatory submission dossiers
- Training centers teaching anesthesia machine maintenance, gas pathway diagnostics, and fail-safe pressure regulation principles
FAQ
Does the R510-31 include an oxygen cylinder or air compressor?
No. The unit is a gas interface only; users must supply their own E-cylinder (for oxygen) or select and install a compatible medical air pump (e.g., RWD AP-200 series).
Is the E-cylinder bracket included with the R510-31?
No. The E-cylinder mounting bracket is an optional accessory (part number BRK-E-R510) and must be ordered separately.
Can the R510-31 be used with human-grade anesthesia machines?
It is validated exclusively for RWD veterinary anesthesia systems (e.g., R510, R610 series). Integration with human-use machines requires independent risk assessment and may violate manufacturer warranty terms.
What maintenance is required?
Quarterly visual inspection of regulator seals and pressure gauge calibration (recommended annually using NIST-traceable equipment); filter elements (if installed downstream) require replacement per ISO 8573-1 service intervals.
Does RWD provide installation support?
Yes. Technical documentation includes English-language installation schematics, torque specifications, and gas pathway leak-testing procedures (using helium mass spectrometry or pressure-decay methods per ISO 13485 clause 7.5.10).
