SRRG-1 Respiratory Rhythm Generator
| Origin | Shanghai, China |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Model | SRRG-1 |
| Pricing | Available Upon Request |
| Respiratory Rate Range | 2–120 RPM |
| Respiratory Rate Accuracy | ±0.2% of set value |
| CO₂ Calibration Gas | 5% v/v CO₂ in balance air (custom gas mixtures available) |
| Inlet/Outlet Interface | Pneumatic push-to-connect fittings (adapters for multiple tubing diameters included) |
Overview
The SRRG-1 Respiratory Rhythm Generator is a metrologically traceable, benchtop calibration source engineered specifically for the verification and periodic verification of capnography and respiratory monitoring functions in medical devices. It operates on the principle of controlled, programmable gas flow modulation to emulate physiologically relevant breathing patterns—enabling precise generation of time-synchronized CO₂ concentration waveforms and discrete respiratory cycles. Designed in strict alignment with JJG 1163–2019 Verification Regulation for Multi-parameter Patient Monitors, the SRRG-1 satisfies Clause 7.4.6.1 (end-tidal CO₂ concentration indication error) and Clause 7.4.6.2 (respiratory rate indication error), making it an essential tool for accredited medical device calibration laboratories, third-party metrology service providers, and in-house quality assurance units operating under GLP or ISO/IEC 17025 frameworks.
Key Features
- Programmable respiratory rate output from 2 to 120 breaths per minute (RPM), with digital setpoint resolution of 0.1 RPM and real-time feedback stabilization ensuring ±0.2% accuracy relative to nominal setting.
- Dual-interface pneumatic architecture: dedicated inlet for certified 5% v/v CO₂ standard gas (traceable to NIM or equivalent national standards), and synchronized outlet delivering calibrated, rhythmically modulated gas pulses with physiological waveform fidelity (square, sinusoidal, or asymmetric profiles configurable via firmware).
- Modular quick-connect interface system featuring ISO 8535–1 compliant push-to-connect fittings; includes interchangeable adapters for 4 mm, 6 mm, and 8 mm ID sampling tubing—compatible with mainstream, sidestream, and microstream capnography modules.
- Embedded pressure and flow monitoring circuitry to detect line occlusion, leak, or insufficient supply pressure—preventing erroneous calibration events and supporting audit-ready operation logs.
- Compact, ESD-safe chassis with CE-marked power supply and IEC 61000-4 electromagnetic compatibility compliance for use in clinical engineering labs and metrology workshops.
Sample Compatibility & Compliance
The SRRG-1 is validated for use with all capnography-enabled patient monitors and standalone end-tidal CO₂ analyzers compliant with IEC 60601-2-56 (Particular requirements for basic safety and essential performance of clinical thermometers) and ANSI/AAMI EC13 (Standard for cardiac monitors). Its gas delivery profile meets the waveform timing and amplitude criteria specified in ISO 80601-2-55 for ventilator-associated monitoring equipment. All calibration gas connections conform to ISO 8535–1 for medical gas systems, and the unit supports traceability documentation aligned with ISO/IEC 17025:2017 Clause 6.6 (Traceability of measurements). Routine verification against NIST-traceable flow and time standards is recommended every 12 months or per internal QA schedule.
Software & Data Management
The SRRG-1 operates in standalone mode without external software dependency; however, optional RS-232 and USB-C interfaces support integration with laboratory information management systems (LIMS) and electronic calibration record platforms. Firmware version 2.1+ enables timestamped event logging—including rate setpoint changes, gas activation cycles, and fault codes—with export capability in CSV format. Audit trail functionality complies with FDA 21 CFR Part 11 requirements when deployed with validated LIMS configurations, including user authentication, electronic signatures, and immutable record retention.
Applications
- Primary calibration of multi-parameter patient monitors per JJG 1163–2019, including verification of EtCO₂ measurement linearity, zero drift, and response time across 0–10% v/v range.
- Performance validation of anesthesia machines, ICU ventilators, and portable capnographs prior to clinical deployment or after repair.
- Supporting ISO 13485-certified manufacturing QA processes where respiratory parameter accuracy must be demonstrated during design verification and process validation.
- Training and competency assessment for biomedical engineers and clinical technology specialists in respiratory metrology principles and regulatory test execution.
- Inter-laboratory comparison studies coordinated under APMP or ILAC MRA frameworks for capnography calibration harmonization.
FAQ
Does the SRRG-1 generate actual CO₂ gas, or does it modulate an external supply?
The SRRG-1 does not contain or generate CO₂ internally. It precisely controls the timing, duration, and flow profile of externally supplied certified CO₂ gas (e.g., 5% v/v in air) through its synchronized valve manifold.
Can the device be used with non-5% CO₂ calibration gases?
Yes—while factory-configured for 5% v/v, the SRRG-1’s flow control algorithm is agnostic to gas composition. Users may substitute other certified gas mixtures (e.g., 1%, 10%, or O₂–CO₂ blends), provided they are compatible with the connected analyzer’s input specifications and regulatory validation scope.
Is firmware upgrade supported in the field?
Yes—firmware updates are delivered via signed .bin files and installed using the included configuration utility; each release includes revision-controlled change logs and impact assessments for metrological validity.
What documentation accompanies the instrument upon shipment?
Each unit ships with a Certificate of Conformance, NIST-traceable calibration report (covering timing and flow verification), user manual (EN/ISO-compliant), and a JJG 1163–2019 clause mapping matrix detailing test coverage per regulation subsection.
