The KARL STORZ LED battery light source (Article number: 11301D4) is a mobile light source designed for generating and transmitting light to KARL STORZ endoscopes in ENT medicine. This device is non-invasive and intended for transient use in invasive procedures through a body orifice.
Function Description
The LED battery light source provides illumination for various ENT procedures. It is designed to be screwed onto the light inlet of KARL STORZ endoscopes or fiberscopes using a suitable adaptor (495G). The device features a simple On/Off switch for operation. A "BOOST" mode is available to increase brightness, which can be activated and deactivated by pressing and holding the On/Off switch. The device signals the end of its battery service life by flashing several times, repeating at 2-minute intervals until the battery is completely discharged (typically after 5-10 minutes).
Important Technical Specifications
- Dimensions (L x H x W): 95 x 40 x 20 mm
- Weight: 80 g (without battery)
- Color temperature: 6,000-6,700 K
- Drip-water protection: None, wipeable, disinfectable
- Protection class: Internal voltage supply
- Power supply (DC): 3 V
- Battery: 2 x CR123A 3 V lithium batteries
- Operating time: 2 hours (with 2 batteries)
- Storage/transport conditions:
- Temperature: -20 °C ... +60 °C
- Relative humidity: 10-90%
- Air pressure: 700-1,080 hPa
- Operating conditions:
- Temperature: 10 °C ... 30 °C
- Relative humidity: 30-70%
- Air pressure: 700-1,080 hPa
The device is compliant with various electromagnetic compatibility standards, including EN/IEC 60601-1-2 for medical electrical equipment. It is designed to operate in a professional healthcare environment, but users should be aware of potential interference from RF wireless communications equipment. Recommended separation distances from such equipment are provided in the manual to ensure proper functionality.
Usage Features
The LED battery light source is indicated for use in procedures such as rhinology, rhinoplasty, sinus surgery, ear diagnostics and surgery, adenotomy, tonsillectomy, tracheotomy, laryngoscopy, endolaryngeal microlarynx and transoral microsurgery, and esophagoscopy, diverticuloscopy. It should only be used by doctors and medical assistants with relevant specialist qualifications.
Key usage instructions include:
- Reading Instructions: Users must carefully read and follow the instructions for use, as well as those for any products used in combination.
- Product Inspection: Before each use, the product must be inspected for visible contamination, good working order, functionality, correct assembly, and completeness.
- Assembly: The light source is screwed onto the endoscope/fiberscope light inlet using a suitable adaptor.
- Operation:
- Switch the product on and off using the designated On/Off switch.
- To activate BOOST mode, press and hold the On/Off switch. Deactivate by pressing and holding again. BOOST mode automatically deactivates after a certain time.
- Safety Warnings:
- High energy/Risk of injury: The light source can reach high surface temperatures. Do not touch the hot light source. Only use with an endoscope/fiberscope. Always switch off before putting down and keep away from the patient.
- High energy/Risk of fire: Do not cover the light source with cloths or similar objects immediately after use due to high surface temperatures.
- High light intensity/Danger of glare: Never look directly into the light outlet of the light source, as it can cause permanent eye damage or blindness.
- Contraindications: The device should not be used for procedures in direct contact with the central nervous system (CNS) and central cardiovascular system.
Maintenance Features
- Battery Replacement:
- Place your thumb on the lid lock.
- Turn the lock counterclockwise and remove the lid.
- Remove the old batteries and insert two new CR123A batteries. Both batteries must be replaced at the same time. Rechargeable batteries must not be used.
- Replace the lid and turn the lock clockwise until it is secure.
- Check that the battery light source is functioning properly and then switch it off.
- Repair: Repair work must only be performed by KARL STORZ or a company authorized by KARL STORZ.
- Disposal: The product meets the requirements of the Directive on Waste Electrical and Electronic Equipment (WEEE). It must be disposed of in accordance with applicable national laws and regulations at a suitable collection point for the reprocessing of electrical and electronic equipment. Contact KARL STORZ SE & Co. KG or an authorized dealer for disposal information.
- Contaminated Products: Contaminated devices may not be shipped. To prevent contact infections, products must first be decontaminated. KARL STORZ reserves the right to send back contaminated products.
- Unsterile Products: The product is not sterile when delivered. The use of non-sterile products poses a risk of infection for patients, users, and third parties. Reprocess the product in line with the reprocessing instructions before initial use and every subsequent use.
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