The ROCAMED MH01 is a 30W Holmium YAG Laser system, designed for surgical procedures across various medical specialties including Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, ENT, and General Surgery. It operates at a wavelength of 2100 nm, delivering energy through a quartz optical fiber with a diameter ranging from 200µm to 1000µm. The device is classified as a Class 4 medical laser according to IEC 60825-1, emphasizing the need for strict safety precautions during its operation.
Function Description
The MH01 laser system is designed to provide efficient and precise energy delivery for a range of surgical applications. Its primary function is to generate laser energy at 2100 nm, which is highly absorbed by water, making it effective for tissue ablation, vaporization, coagulation, and hemostasis. The system supports both pulsed and continuous wave modes, with a maximum frequency of 25Hz. The user interface, accessible via a touch screen display, allows for intuitive control over various parameters, including energy output (Joules/Pulse), repetition rate (Hertz), and selection of specific emission modes like Lithotripsy (for stone fragmentation or dusting) and Tissue (for resection, cutting, or coagulation).
The device incorporates an RFID system for fiber recognition, ensuring that only compatible and authorized optical fibers are used. This system also tracks fiber usage, including the number of times a fiber has been used and the total energy emitted through it, which is crucial for maintaining performance and safety.
Important Technical Specifications
- Laser Type: Flashlamp Pumped Ho:YAG
- Wavelength: 2100 nm
- Power to Tissue: 30 Watts
- Energy/Pulse: 0.2-4 J
- Application Mode: Pulsed
- Time Function: Single pulse; Pulse sequence
- Pulse Width: 150 - 850 µs
- Repetition Rate: 3-25 Hz
- Delivery Device: Wide range of flexible silica frontal fiber (sterile and reusable)
- Aiming Beam: Diode laser, green, 532nm (<5mW, adjustable by software)
- Dimensions: 332 (W) x 967 (D) x 938 (H) mm
- Weight: 60 kg
- Electrical Requirements: 100-120 Vac, 50/60 Hz, 16A or 200-240 Vac, 50/60 Hz, 10A
- Ingress Protection: IP20
- Operating Temperature: 10°C - 30°C
- Storage Temperature: 5°C - 40°C
- Relative Humidity: from 30% to 85% (no condensing)
- Atmospheric Pressure: 800-1060 hPa
- Cooling System: Air cooled (closed water-air cooling circuit)
- Nominal Ocular Hazard Distance (NOHD): 1000 W/m²
- Maximum Permissible Exposure (MPE): 0.44 m
- Optical Density (OD): 2
Usage Features
The MH01 is designed for ease of use with several features that enhance operational efficiency and safety:
- Touch Screen Display: A central control panel allows operators to select treatment modes (Lithotripsy, Tissue), adjust laser parameters (frequency, energy/pulse), and monitor the system's status.
- RFID Fiber Recognition: Automatically identifies the connected optical fiber, ensuring compatibility and tracking its usage history. This feature helps prevent the use of expired or unauthorized fibers.
- Pilot Laser: A green aiming beam (532nm) with adjustable brightness (1-100%) assists in precise targeting during procedures.
- Footswitch Control: Provides hands-free control over laser emission, enhancing surgical precision and safety. The system supports both single and double footswitch configurations.
- Emergency Stop Button: A prominent red button for immediate shutdown of the laser emission in case of an emergency.
- Interlock Connector: Allows for connection to a remote interlock system, which can prevent laser emission if an access door to the operating room is open, ensuring a controlled environment.
- Water Cooling System: The internal closed-loop water-air cooling system maintains optimal operating temperatures for the laser, ensuring stable performance.
- User Manual Access: The electronic version of the user manual is consultable directly from the device's display, providing immediate access to information.
- Language Selection: The user interface supports multiple languages, including English, German, Italian, French, and Spanish.
Maintenance Features
Regular maintenance is crucial for the longevity and safe operation of the MH01. The manual outlines several key maintenance tasks:
- Device Cleaning: The exterior of the device and the optical fiber connection port should be cleaned with a damp cloth and a caustic solution such as foam. Alcohol solution can be used for the fiber connection port.
- Laser Maintenance and Technical Check: The manufacturer recommends a review of the device by a qualified technician every 12 months. This includes checking the laser's intensive use, dust, or continuous movement, which may require more frequent review.
- Safety Labelling Check: Verification of the integrity and readability of all safety labels on the device is essential.
- Water Cooling System Check: The water level in the cooling system should be checked regularly (every 6 months) and refilled if necessary to maintain optimal performance.
- Check of the Line Cable: The power line cable should be checked for mechanical integrity and signs of deterioration over time.
- Optical Fiber Maintenance: Fibers should be sterilized before use. The aiming beam pattern should be checked to verify the effective quality of the beam. The RFID system tracks fiber usage, and fibers should be replaced when expired or damaged. Fiber stripping and cleaving are important for optimal energy transmission.
- Blast Shield Replacement: The blast shield, which protects against accidental laser emission, must be replaced if damaged.
- Troubleshooting Guide: The manual includes a comprehensive troubleshooting table to assist users in identifying and resolving common issues, such as key switch problems, lamp errors, flow errors, temperature errors, shutter errors, fiber errors, remote interlock errors, footswitch errors, energy warnings, and no correspondence between displayed energy and treatment effects.
- Customer Service: ROCAMED provides customer support for repairs, maintenance, and training. Contact information for the service department is provided for assistance with any issues.
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