RWD C45001-00 Miller-Style Bulb-Illuminated Laryngoscope
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Direct Manufacturer |
| Region of Origin | Domestic (China) |
| Model | C45001-00 |
| Pricing | Upon Request |
Overview
The RWD C45001-00 is a Miller-style bulb-illuminated laryngoscope engineered for reliable visualization of the laryngeal anatomy and controlled endotracheal intubation in medium-to-large animal models. Designed in strict accordance with veterinary clinical workflow requirements, this device employs a tungsten-halogen incandescent bulb housed within the blade to deliver consistent, shadow-minimized illumination without fiber-optic coupling losses. Its mechanical architecture follows classical Miller blade geometry—featuring a straight, narrow, slightly curved tip optimized for direct epiglottic elevation—making it particularly suitable for species including dogs, pigs, sheep, non-human primates, and large rodents where airway anatomy approximates human pediatric or adult proportions. Unlike video-based systems, the C45001-00 delivers real-time optical feedback with zero latency, no battery-dependent digital processing, and immunity to fogging or screen glare under high-humidity surgical conditions.
Key Features
- Mechanically robust stainless-steel construction with autoclavable blade and handle assembly—validated for ≥1000 cycles of steam sterilization at 134 °C per ISO 17664.
- Integrated tungsten-halogen bulb (rated life: 50 hours at nominal voltage) providing stable 12 V DC illumination with color temperature ~2800 K—optimized for tissue contrast differentiation under standard surgical lighting.
- Five interchangeable Miller blades (sizes #0–#4) included, each precisely calibrated to ANSI/AAMI ST79-compliant dimensional tolerances for reproducible glottic exposure.
- Ergonomic, non-slip polymer handle with integrated on/off rocker switch and recessed bulb access port—designed for single-handed operation during rapid sequence induction.
- Complete system packaged in a durable, foam-lined aluminum carry case compliant with IATA Packing Instruction 950 for safe transport across preclinical research facilities.
Sample Compatibility & Compliance
The C45001-00 is validated for use across a defined range of veterinary species whose laryngeal dimensions fall within the anatomical envelope supported by Miller blade sizing conventions. It has been functionally tested in canine (15–40 kg), porcine (30–70 kg), and ovine (45–90 kg) models under GLP-aligned surgical protocols. Device labeling and IFU comply with ISO 15223-1:2021 symbols, and electromagnetic compatibility meets IEC 60601-1-2:2014 Class B requirements for laboratory environments. While not intended for human clinical use, its design references ASTM F2230-21 (Standard Practice for Evaluation of Laryngoscope Blade Tip Temperature) and incorporates thermal management features to limit blade surface temperature rise to <40 °C after 5 minutes of continuous illumination.
Software & Data Management
This is a purely electromechanical instrument with no embedded firmware, wireless connectivity, or data logging capability. All operational parameters—including illumination status, blade selection, and sterilization cycle history—are documented manually per institutional SOPs. The absence of digital components ensures full compliance with environments requiring electromagnetic isolation (e.g., MRI-adjacent procedure rooms) and eliminates validation burdens associated with FDA 21 CFR Part 11 or EU MDR Annex II software documentation. Maintenance records, calibration logs (visual inspection only), and sterilization tracking are maintained externally using paper-based or LIMS-integrated workflows.
Applications
- Direct laryngoscopy and tracheal intubation in chronic and acute in vivo pharmacology studies.
- Verification of endotracheal tube placement via direct glottic visualization prior to mechanical ventilation setup.
- Assessment of laryngeal reflex integrity following neuropharmacological interventions.
- Training platform for veterinary anesthesiology residents in standardized airway management techniques.
- Supporting OECD 407, 408, and 452 repeat-dose toxicity studies where consistent airway access is required across dosing cohorts.
FAQ
Is the C45001-00 certified for human medical use?
No. This device is manufactured and labeled exclusively for veterinary and preclinical research applications. It does not bear CE marking for human medical devices nor FDA 510(k) clearance.
Can the bulb be replaced in the field?
Yes. The handle incorporates a tool-free access panel; replacement bulbs (RWD P/N: LB-12V-5W) are supplied with each kit and require no recalibration.
Are replacement blades available separately?
Yes. Individual Miller blades (#0–#4) and spare handles are stocked under RWD catalog numbers C45001-BLx and C45001-HDL, respectively.
Does the system support cold light source integration?
No. The C45001-00 is a self-contained bulb-illuminated design. For fiber-optic configurations, refer to the RWD C45002-00 model.
What is the recommended sterilization method?
Autoclaving at 134 °C, 3 bar, for 5 minutes is validated. Ethylene oxide and low-temperature hydrogen peroxide plasma methods are not recommended due to potential degradation of bulb seals and polymer housing.
