The SOPRO 281 is a 30-watt LED light source specifically designed for endoscopic diagnostic applications across various medical fields, including ENT, gynecology, urology, and veterinary medicine. This medical device is intended for professional use in consulting rooms and operating theatres by qualified surgeons during endoscopic examinations. Its design emphasizes ease of use, powerful illumination, and precise manual light intensity regulation, making it a versatile tool for multiple disciplines.

Function Description

The primary function of the SOPRO 281 is to illuminate the work area through an endoscope. An LED is supplied with current according to the intensity setting, emitting light that is focused towards the exit of an optical fiber. This optical fiber then transmits the light to the endoscope, effectively lighting the working area. The device incorporates an electronic iris with a fiber optic sensor, an automatic thermal protection system, and a power level memory.

Important Technical Specifications

LED Technology: The device utilizes advanced LED technology for illumination.
Power Rating: 30W, providing light intensity equivalent to a 100-watt Xenon lamp.
Colour Temperature: > 4500°K.
Typical LED Life Span: Approximately 50,000 hours under normal operating conditions.
Compatible Light Cable: Exclusively designed for "Storz" type light cables. Recommended cable diameters are Ø 4.8mm for endoscopes > 4mm and Ø 3.5mm for endoscopes <= 4mm.
Electronic Aperture: Features an electronic iris for precise light control.
Light Intensity Adjustment: Manual.
Anti-Blinding System: Equipped with a light cable sensor to prevent blinding.
Automatic Overheat Protection System: Automatically stops light intensity if the internal temperature becomes excessive.
Power Level Memory: Retains the last used light intensity setting.
Transformer Supply Voltage: 100-240VAC / 50-60Hz.
Transformer Output: 12VDC.
Power Consumption: 30VA.
Dimensions: Length: 180mm; Depth: 95mm; Height: 35mm.
Weight: 320g.
Service: Continuous operation.

Environmental Conditions:

Operating Temperature: +10°C to +40°C.
Operating Humidity: 30% to 75%.
Transport and Storage Temperature: -10°C to +45°C.
Transport and Storage Humidity: 20% to 85%.
Atmospheric Pressure (Operation, Transport, Storage): 700hPa to 1,060hPa.
Splash Protection: Not splash-proof (IPX0).
Flammable Anesthetics: Not suitable for use in the presence of flammable anesthetic gas mixtures with air, oxygen, or nitrous oxide.

Regulatory Compliance:

Electrical Safety Class: Class 2, Type BF.
EU Directive: Compliant with EU directive 93/42/EEC – Class I.
International Standards: Compliant with IEC 60601-1, IEC 60601-2-18, IEC 60417, and EN 980.
Laser Class: Risk group 2 (IEC 62471).

Usage Features

Installation: The device should be placed on a stable surface with at least 15 cm of clear space around it for adequate ventilation. It is crucial not to cover the side and back air fans. The installation does not require special training, but users must refer to the manual.
Power Supply Connection: Use only the supplied FRIWO type FW 8030M/12 wall-mounted transformer. Connect the power cable to the light source (A) and the power adapter to the mains supply. Ensure easy access to the power socket for disconnection.
Light Cable Connection: The light source is equipped with a fixed adapter for "Storz" type light cables. Insert the light cable into the designated opening (B) until a clicking noise indicates it is locked. Connect the other end of the light cable to the endoscope. Before connecting an endoscope, check its condition (clean distal lens, quality of optical fibers).
Switching On: The LED source has a switch (C) on top. After switching on, a 3-second automatic test is performed. The lamp then enters standby mode, and the indicator light (L) flashes yellow.
Adjusting Light Intensity:
- Upon initial power-on, the device starts at maximum power.
- Pressing button (C) sets the luminous power to maximum (continuous blue light).
- A long press on (C) decreases the luminous power (flashing blue) to the low intensity level (continuous green light).
- From the low intensity level, another long press on (C) increases the luminous power (flashing green) back to maximum (continuous blue light).
- The LED may flash green or blue to indicate whether a long press will increase or decrease the luminous power.
Power Level Memory: To put the LED into standby mode (light and fans off), press button (C) briefly. Pressing it again will restore the light to the last used luminous power setting (unless there was a power cut).

Maintenance Features

General Maintenance: No particular maintenance operation is needed.
Fan Obstruction: Ensure that the fans (D) are not obstructed by dust. If they are, disconnect the device from the mains supply and vacuum the dust.
Troubleshooting:
- Indicator light (L) does not go on: Check if the mains transformer is properly connected.
- Light is on but luminous power is poor: Check user settings (Chapter 6), the condition of the light cable, and the optical system.
- Images are too bright or saturated: Check if the light intensity is set too high and review camera settings.
- No light, but fans continue to operate:
  - Check if the light cable is disconnected.
  - The light source has an integrated safety device that cuts power to the LED if the internal temperature is too high. Once the temperature drops, the lamp can be used again. Ensure sufficient space (minimum 15 cm) around the device for cooling and that ventilation slots (D) are not covered.
- Light switches on and off alternately: Check if the light cable is correctly connected.
- Indicator light illuminates cyan: The light source is in temperature protection mode. Ensure the specified operating temperature range (+10°C / +40°C) is observed.
Decontamination:
- This procedure applies exclusively to the enclosure of the LED light source.
- The LED light source is not heat-resistant and must not be immersed in liquid. Disinfection is performed using a non-woven fabric cloth with a detergent-disinfectant.
- The choice of disinfectant should be from category F of the French Society of Hospital Hygiene's approved list.
- Decontamination is the sole responsibility of the personnel involved.
- Alkaline solutions for disinfecting certain medical products are NOT allowed for this device.
- The device is not autoclavable.
- For hygiene and to prevent contamination, the light cable must be changed between patients according to endoscopic practice rules (accessory not supplied, must be sterilized before each use).
Returning for Repair: If a fault persists, the device must be disinfected and returned in its original packaging. Any damages during transport should be noted on the delivery note and confirmed to the carrier within 48 hours.

COMEC SOPRO 281 - Page 5

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