The Mach LED 3 is a Class I medical device, designed for illuminating surgical sites in medical facilities such as laboratories, hospitals, or doctor's offices. It provides focused, glare-free, and shadow-free light, enabling users to perform diagnoses or medical interventions. This operating light is not fail-safe when used as a single light and is not intended for use in potentially explosive atmospheres, though its use near high-frequency surgical equipment is permissible. When illuminating the face, prolonged illumination of the open human eye should be avoided.
Technical Specifications:
- Protection Class: I
- IP Protection Class: IP 42
- Input Voltage (Power Supply): 100-240 V AC, 50/60 Hz
- Input Voltage (Light Body): 24-30 V DC
- Power Consumption (Mach LED 3SC): 45 W (without camera), 50 W (with camera)
- Power Consumption (Mach LED 3 Smart): 60 W (without camera), 65 W (with camera)
- Current (Mach LED 3SC): 1.7 A max. (without camera), 1.9 A max. (with camera)
- Current (Mach LED 3 Smart): 2.5 A max. (without camera), 2.7 A max. (with camera)
- Operating Time: Continuous operation possible
- Expected Life: 10 years (after which more frequent servicing is required for safe operation)
- Central Light Intensity (at 1 m): 140,000 lux (for both Mach LED 3SC and Mach LED 3 Smart)
- Light Field Diameter d10: 170 mm (for both Mach LED 3SC and Mach LED 3 Smart)
- Light Field Diameter d50: 100 mm (for both Mach LED 3SC and Mach LED 3 Smart)
- Residual Light Intensity (one shadower): 63% (3SC), 61% (Smart)
- Residual Light Intensity (two shadowers): 49% (3SC), 49% (Smart)
- Residual Light Intensity (normed tube): 100% (for both 3SC and Smart)
- Residual Light Intensity (normed tube, one shadower): 63% (3SC), 61% (Smart)
- Residual Light Intensity (normed tube, two shadowers): 49% (3SC), 49% (Smart)
- Illumination Depth (20%): 1200 mm (for both 3SC and Smart)
- Illumination Depth (60%): 510 mm (3SC), 530 mm (Smart)
- Radiation Intensity in the Field (at 1 m): 490 W/m² (3SC), 499 W/m² (Smart)
- Max. Radiation Intensity in the Field (at 0.80 m): 770 W/m² (3SC)
- Max. Radiation Intensity in the Field (at 0.89 m): 537 W/m² (Smart)
Usage Features:
The Mach LED 3 features a control panel with several functions:
- ON/OFF: Toggles the light on or off.
- DEPTH: Activates or deactivates the depth light function.
- LASER: Activates or deactivates the optional laser. The laser beam must not enter the eyes of the patient or user, as the eyelid closing reflex may be impaired.
- SYNC: Transfers light intensity, color temperature, and Endo-mode settings to other lights (optional).
- ENDO: Activates or deactivates Endo-mode, which provides reduced light for endoscopy applications.
- INTENSITY (+/-): Adjusts the light intensity.
- COLOR (+/-): Adjusts the color temperature (Mach LED 3 Smart model only).
- Display Indicators: Shows the relative size of the adjusted light field, the set light intensity, and the set color temperature in Kelvin.
Safety Instructions:
- Users must observe the instructions for use for safe handling.
- To avoid electric shock, the device must only be connected to a supply network with a protective earthing conductor.
- A primary-side ON/OFF switch must be provided on site to isolate the system from the supply network, meeting IEC 61058-1 requirements for nominal voltage peaks of 4 kV.
- The device is not designed for operation in oxygen-enriched environments.
- The lamp must only be used for its intended purpose.
- The lamp is equipped with a sterilizable handle and must only be used with this handle.
- Modifications to the lamp are prohibited and will invalidate the manufacturer's certificate of conformity and all warranty claims.
- Only manufacturer-approved or supplied mains units (transformers) should be used.
- Installation, maintenance, and repair work may only be carried out by the manufacturer or specially trained staff.
- The unprotected human eye can be damaged by direct light. Do not look directly into the light beam or continuously point it at the patient's unprotected eye.
- When positioning the light body, there is a risk of injury (e.g., crushing) and collisions with other objects or walls.
- Falling parts could injure the patient or lead to wound infection.
- The rating plate and warning labels must not be removed.
- Maintenance and repair activities are not permitted while the lamp is in use.
- Lights with camera preparation equipment may only be used with the camera or camera bay cover installed.
- Simultaneous use of several lights to illuminate a wound area may exceed the maximum allowed energy input (1,000 W/m²) and cause excessive heat. The user is responsible for ensuring this limit is not exceeded.
- Additional equipment connected to medical electrical equipment must conform to relevant IEC or ISO standards (e.g., IEC 60950 or IEC 62368 for data processing equipment). All configurations must meet the requirements for medical electrical systems (IEC 60601-1, Section 16).
- The lamp is suitable for use with an RF surgical device; a minimum distance of 50 cm must be maintained between the surgical light (including suspension system) and RF electrode cables.
- Portable and mobile RF communications equipment can affect medical electrical equipment and must not be used within 30 cm of the light, including the cable.
- Avoid using this equipment immediately next to or stacked with other equipment, as this may result in faulty operation. If such use is necessary, the devices should be observed to ensure proper functioning.
- Using accessories, converters, or cables other than those specified by the manufacturer may result in increased electromagnetic interference or reduced immunity.
- The light must not be operated if the housing, cable, or electromagnetic shielding is damaged.
Maintenance Features:
- Cleaning and Disinfection: Must only be performed by trained staff, observing all respective requirements.
- Housing/Protective Screen: Can be cleaned and disinfected with common commercial agents. Do not use cleaning agents or disinfectants containing active substances based on biguanides or phenols. Cameras must be removed, and the camera bay cover installed before cleaning and disinfection. Only polycarbonate (PC)-approved cleaning agents should be used for the protective screen. Always wipe with a damp (never dry) cloth and then with an anti-static (lint-free) cloth to prevent mechanical damage.
- Sterilizable Handle: Must be cleaned/disinfected before each use. It can be steam sterilized (max. 200 sterilization cycles for max. 5 minutes at max. 134°C). Check for visible damage, fouling, and manufacturing date before installation. Damaged, dirty, or handles older than two years must not be used.
- Faults: In case of unusual operating conditions or error messages, the lamp must not be used. For troubleshooting, disconnect the lamp from the mains for about 30 seconds. If faults persist, contact a trained service technician with the error code.
- Electromagnetic Compatibility (EMC): Medical electrical equipment is subject to special EMC precautions. The Mach LED 3 has been tested for use in professional healthcare settings.
- Disposal: The light does not contain harmful substances. Components should be disposed of appropriately at the end of the product's life, with careful material separation. Electrical circuit boards should be recycled, and the housing and other components disposed of according to their materials.
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