The Mach LED 150 is a Class I medical product designed to illuminate an operating site in medical facilities such as laboratories, hospitals, or doctor's practices. It provides focused, low-glare, shadow-free light, enabling users to perform diagnoses or medical interventions. This device is intended for use by trained medical staff.
Function Description:
The Mach LED 150 operating light provides illumination for medical procedures. It features adjustable brightness, with six levels ranging from 50% to 100%. The lowest brightness level activates an endoscopy mode. The light field can be focused by turning the handle, and the lamp body can be positioned using either the handle or a handle bar. For the Mach LED 150MC model, additional features include color temperature adjustment. The device is not designed for operation in environments enriched with oxygen and should not be used as a single, fail-safe light source. Continuous illumination of the open human eye should be avoided when illuminating the face area.
Important Technical Specifications:
- Class of protection: 1
- IP protection class: IP 42
- Input voltage (power supply): 100-240 V AC, 50/60 Hz
- Input voltage (light body): 24 V DC
- Power consumption: 24 W (29 W for Mach LED 150 MC P)
- Current: 1.0 A max (1.2 A max for Mach LED 150 MC P)
- Examination time: Continuous operation possible
- Expected life: 10 years (with more frequent servicing required at the end of this period for safe operation)
- Central illuminance (distance 1 m):
- Mach LED 150F, 150: 110,000 Lux
- Mach LED 150FP, 150MC P: 130,000 Lux
- Mach LED 150MC: 110,000 Lux
- Light field diameter d10: Ranges from 157 mm to 206 mm depending on the model.
- Light field diameter d50: Ranges from 83 mm to 113 mm depending on the model.
- Residual light intensity (one shadower): 0% across all models.
- Residual light intensity (two shadowers): Ranges from 45% to 53% depending on the model.
- Residual light intensity (normed tube): 100% across all models.
- Residual light density (normed tube, one shadower): 0% across all models.
- Residual light density (normed tube, two shadowers): Ranges from 46% to 53% depending on the model.
- Depth of illumination (20%): Ranges from 1544 mm to 1800 mm depending on the model.
- Depth of illumination (60%): Ranges from 803 mm to 870 mm depending on the model.
- Radiation intensity in the field (distance 1 m): Ranges from 393 W/m² to 489 W/m² depending on the model.
- Radiation intensity in the field (at specified distances): Ranges from 551 W/m² to 695 W/m² depending on the model and distance.
- Ambient temperature for operation: +10°C to +30°C
- Relative air humidity for operation: 30% to 75% RH
- Air pressure for operation: 700 hPa to 1060 hPa
Usage Features:
- ON/OFF Switch: The light can be switched on/off by pressing and holding the ON/OFF button for one second.
- Brightness Adjustment: Brightness can be adjusted in six levels, from 50% to 100%. The lowest level activates endoscopy mode, indicated by only the top LED lighting up.
- Light Field Focusing: The light field can be focused by turning the handle.
- Lamp Body Positioning: The lamp body can be positioned using the handle or a dedicated handle bar.
- Sterilisable Handle: The lamp is equipped with a sterilisable handle that must be used with the device. This handle can be steam sterilized (max. 200 sterilization cycles for max. 5 minutes at a max. temperature of 134°C). Users must check the handle for visible damage, fouling, and manufacturing date before installation, and damaged or dirty handles, or handles older than two years, must not be used.
- Electromagnetic Compatibility (EMC): The device is medical electrical equipment subject to special precautionary measures regarding EMC. It must be installed and put into service according to EMC instructions. It is intended for use in professional healthcare facilities. Portable and mobile RF communications equipment should not be used within 30 cm of the light. When used with an RF surgical device, a minimum distance of 50 cm must be maintained between the surgical light and the RF electrode cables. The use of different accessories, converters, or cables not stipulated by the manufacturer may result in increased electromagnetic interference or reduced immunity. The light must not be operated if its housing, cable, or electromagnetic shielding is damaged.
Maintenance Features:
- Installation, Maintenance, and Repair: These tasks must only be carried out by the manufacturer or by specially trained staff.
- Maintenance Schedule: Maintenance must be carried out at least every two years.
- Cleaning and Disinfecting: Cleaning and disinfecting work must only be done by trained staff, following specific requirements detailed in the manual.
- Housing/Protective Screen: The housing and protective screen can be cleaned and disinfected with many common/commercially available materials. However, cleaning agents or disinfectants containing active substances based on biguanides, phenols, chlorides, or percompounds must not be used. Only cleaning agents approved for polycarbonate (PC) should be used on the protective screen. A damp cloth (never dry) should be used for wiping, followed by an anti-static agent (lint-free cloth) to protect against mechanical damage.
- Sterilisable Handle: The handle must be cleaned/disinfected before each use.
- Reporting Obligations: All serious incidents related to the product must be reported to the manufacturer and the competent authority.
- Disposal: The light does not contain harmful substances. Components should be disposed of appropriately at the end of the product's life. Electrical circuit boards should be recycled, and the housing and other components disposed of according to their materials.
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