The Harmony® LED385 Examination Lighting System is a medical device designed to provide cool, color-corrected, and shadow-controlled illumination for examination fields. It is suitable for use in various healthcare settings, including physician's offices, outpatient centers, intensive care units, recovery rooms, first aid stations, and other diagnostic specializations.
Function Description:
The primary function of the Harmony LED385 is to deliver high-quality illumination for medical examinations. It utilizes LED technology to ensure a cool light source, preventing discomfort for both patients and healthcare professionals during prolonged use. The system's design focuses on color correction to provide accurate tissue rendition and shadow control to minimize obstructions in the examination field, enhancing visibility and diagnostic accuracy. The lighthead can be easily positioned using either a sterilizable handle or side handles, offering flexibility and precision during procedures.
Important Technical Specifications:
-
Illumination Performance:
- Central Illuminance: 4,645 fc (50,000 lux)
- Pattern Size (D10): 6" (152 mm)
- Depth of Illumination: 59" (1499 mm)
- Peak Total Irradiance: 119 W/m²
- Color Temperature: 5,000K (±10%K)
- Color Rendering Index (CRI): >90
- Average Lamp Life: 30,000 hours
-
Electrical Specifications:
- Power Input: 100-240 V ac, 50/60 Hz, 0.5-0.25 Amps
- Fuses: GMD 2 Amps
- Class 1 Equipment
- Type B Equipment
- Ordinary Equipment (enclosed equipment without protection against ingress of water)
- Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
-
Environmental Conditions:
- Transport/Storage:
- Temperature: -50 to 140°F (-15 to 60°C)
- Humidity: 10 to 75% relative humidity, 500 to 1060 hPascals
- Installation Site:
- Temperature: 50 to 104°F (10 to 40°C)
- Humidity: 30 to 75% relative humidity, 700 to 1060 hPascals
Usage Features:
- Control Keyboard: The lighthead features a membrane control keyboard for intuitive operation. It includes an On/Off button and buttons to increase (+) or decrease (-) lighthead intensity (brightness). Three green micro-LEDs indicate the current intensity level.
- Positioning: The lighthead can be positioned using either a sterilizable handle or side handles, allowing for precise adjustment of the examination field. The ceiling-mounted version offers a wide range of motion, including 300° rotation at the ceiling anchoring tube, 25° and 45° articulation at the horizontal arm, and 180° rotation at the lighthead yoke. The mobile floor stand version provides similar flexibility with 300° rotation at the stand extension and 180° rotation at the lighthead yoke.
- Mobile Floor Stand Version: This version is equipped with locking casters for easy relocation and stability. Users must secure the two locking casters before use. The power plug should be inserted into a contact-protected power socket that is properly installed and grounded according to national and local electrical codes.
- Sterilizable Handle: The system includes a sterilizable handle that can be easily uninstalled and reinstalled by pressing two lateral safety keys. This feature ensures aseptic conditions during surgical or sensitive examinations.
Maintenance Features:
- Cleaning:
- General Cleaning/Disinfecting: The lighthead and system components should be cleaned with a soft cloth dampened with an approved cleaning or disinfecting solution. It is crucial to avoid spraying cleaning products directly onto the equipment to prevent fluid leakage into the interior. Abrasive pads, cleansers, gasoline, paint thinners, alkaline detergents, or acids should not be used as they can damage plastic and painted metal surfaces. Always follow manufacturer instructions for cleaning product concentrations.
- Sterilizable Handle Cleaning: The handle should be cleaned with a detergent that is medium alkaline and free of active chlorine. Disinfection can be performed using alcohol or aldehyde-based products approved for polysulfone (PSU).
- Sterilization: The handle can be steam sterilized at 250°F (121°C) for 25-30 minutes (19 psig/1.3 bar) or at 273°F (134°C) for four minutes (33 psig/2.3 bar). The handle is designed to withstand up to 300 steam sterilization cycles.
- Preventive Maintenance Schedule (2x per year):
- Discuss equipment operation with the operator.
- Check the overall lighting system for appearance, visual damage, and missing parts.
- Verify that the light does not flicker.
- Check for proper installation.
- Check for drift and ease of movement.
- Verify intensity change operates properly.
- Verify the unit has proper labeling.
- Clean the area and equipment as needed.
- Adjustments:
- Spring Arm Adjustment: If the lighthead does not maintain its position, the spring arm tension may need adjustment. This involves sliding back a rubber grommet and cover, then inserting a pin into holes in a ring nut to rotate it, increasing or decreasing spring tension.
- Braking Force Adjustment: If the lighthead does not automatically hold its position, the braking force can be adjusted using a 2.5 mm hexagonal Allen wrench to rotate arm brake screws clockwise to increase friction.
- Troubleshooting: A dedicated section provides guidance for common operational issues, such as the lighthead not remaining in position, not working, flickering, or not turning on. Solutions range from checking power supply and fuses to adjusting brakes or contacting STERIS for electronic damage.
- Spare Parts: A list of recommended spare parts, including the sterilizable handle, PC board, and membrane keypad, is provided for maintenance and repair.
- Safety Precautions: The manual emphasizes strict adherence to safety precautions, including disconnecting utilities before servicing, avoiding flammable anesthetics, and ensuring that repairs and adjustments are performed only by trained, qualified personnel to prevent personal injury, equipment damage, and warranty invalidation.
The Harmony LED385 Examination Lighting System is designed for reliability and ease of use, with comprehensive instructions for both operation and maintenance to ensure safe and effective performance in clinical environments.
Need help?
General
To Next Page