RWD R600-RL-0.5L Reusable Latex Resuscitation Bag

Overview

The RWD R600-RL-0.5L Reusable Latex Resuscitation Bag is a manually operated, self-inflating ventilation device engineered for reliable, short-term assisted ventilation in clinical, emergency, and preclinical research settings. Designed in accordance with ISO 10651-4:2017 (Lung ventilators — Part 4: Requirements for manually operated resuscitators), this device operates on the principle of positive-pressure ventilation via manual compression of an elastic reservoir bag, delivering oxygen or air-oxygen mixtures to patients with compromised spontaneous breathing. Its 0.5-liter internal volume is optimized for neonatal and pediatric applications—particularly infants weighing less than 10 kg—where precise tidal volume control and low resistance to flow are critical. The bag features integrated one-way valves, pressure relief (pop-off) mechanisms rated at 40 ± 5 cm H₂O, and compatibility with standard 15 mm/22 mm conical connectors per ISO 5356-1, ensuring interoperability with endotracheal tubes, laryngeal mask airways (LMAs), and anesthesia circuits.

Key Features

• Medical-grade natural latex construction offering high elasticity, fatigue resistance over repeated compression cycles, and proven gas impermeability under clinical pressure ranges.
• Integrated adjustable pressure-limiting valve compliant with ISO 10651-4 safety thresholds; prevents gastric insufflation and barotrauma during manual ventilation.
• Smooth, non-stick inner surface minimizes residual moisture retention and facilitates thorough cleaning between uses.
• Reinforced neck flange with standardized 15 mm internal/22 mm external conical taper ensures secure, leak-free attachment to airway adjuncts and oxygen reservoirs.
• Optimized wall thickness distribution (0.35–0.45 mm) balances compressibility force (≤ 12 N at full stroke) with structural integrity during high-frequency use.
• Marked with permanent laser-etched batch number, manufacturing date, and volume calibration reference for traceability and quality assurance.

Sample Compatibility & Compliance

The R600-RL-0.5L is validated for use with ambient air, medical oxygen (90–100%), and oxygen–air blends delivered via wall supply or portable cylinders. It supports integration with HEPA-filtered breathing circuits and is compatible with common humidification systems used in transport ventilators. All materials comply with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization), and USP Class VI biological reactivity testing. The product is manufactured under a certified ISO 13485:2016 quality management system and meets essential requirements outlined in the EU MDR 2017/745 Annex I (General Safety and Performance Requirements). Device labeling includes bilingual English–Chinese instructions for use (IFU), contraindications, and reprocessing guidelines aligned with AAMI ST91:2023 for reusable respiratory care equipment.

Software & Data Management

As a purely mechanical, non-electronic resuscitation device, the R600-RL-0.5L does not incorporate embedded electronics, firmware, or data logging capabilities. Its operation requires no software interface, eliminating cybersecurity risks, battery dependency, or validation overhead associated with digital components. This analog architecture ensures immediate deployability in power-outage scenarios, electromagnetic interference (EMI)-intensive environments (e.g., MRI suites), and resource-limited field conditions. Reprocessing records—including cleaning agent lot numbers, sterilization cycle parameters, and visual inspection logs—must be maintained manually per institutional GLP/GMP or Joint Commission EC.02.05.01 standards. No FDA 21 CFR Part 11 electronic signature functionality applies, as no digital audit trail is generated.

Applications

• Neonatal resuscitation during delivery room stabilization (per ILCOR 2020 and AAP/NRP guidelines).
• Emergency airway management in ambulance, battlefield, or disaster triage settings.
• Controlled ventilation during procedural sedation in outpatient clinics and dental operating rooms.
• Preclinical pharmacology studies requiring transient respiratory support in rodent and rabbit models (e.g., post-anesthetic recovery, toxicology endpoints).
• Training simulations for ACLS, PALS, and BLS certification programs—where tactile feedback and realistic bag compliance are pedagogically essential.

FAQ

What is the recommended maximum number of reuse cycles for the R600-RL-0.5L bag?

Based on accelerated aging and compression fatigue testing per ISO 10651-4 Annex C, the bag maintains functional integrity for ≥ 500 autoclave cycles or ≥ 1,000 EtO sterilization cycles when reprocessed according to RWD’s validated IFU.
Can this bag be used with CPAP or PEEP valves?

Yes—when connected in-line with ISO-certified spring-loaded or adjustable PEEP valves (e.g., RWD P-Valve series), it delivers stable backpressure up to 15 cm H₂O without compromising valve response time or bag recoil.
Is the latex material suitable for users with Type I hypersensitivity?

No—this product contains natural rubber latex proteins and is contraindicated in patients or operators with documented IgE-mediated latex allergy. RWD offers alternative silicone-based R600-R series bags for such cases.
Does the bag require calibration or periodic metrological verification?

No—volume accuracy is ensured during molding and verified via gravimetric displacement at final inspection. No field recalibration is necessary or supported.
How should residual detergent be verified after cleaning?

Residual protein and detergent levels must be confirmed using colorimetric assays (e.g., Pierce BCA) or conductivity testing (< 5 µS/cm rinse water), per AAMI TIR34:2022 recommendations for respiratory device reprocessing.