Licht am Ende des Zulassungstunnels Photonic‘s small ATO surgery lights undergo a technical redesign due to the MDR. The result is an innovative feature for endoscopy and a great deal of registration expertise, which is now available to all customers. 

Performing concentrated visual examinations for hours on end is a mental and physical feat for physicians, and the thing they rely most on is an optimal illumination of the
wound area. But it makes a great difference whether the area of intervention is right under the surgeon‘s eyes or whether they have to navigate on screen during minimally
invasive operations. Too much light would cause disturbing reflections on the screen.

In conventional operating theatres, however, a high colour rendering index and excellent depth illumination are required. Very few manufacturers can meet both of these requirements with a single device. Photonic is now launching its ATO ML 1000B and ATO ML 600B small surgery light series, which offer both ideal colour rendering and an ENDO mode. ”In this case, the light is reduced to a minimum to place the focus on the video signal of the endoscope camera, while keeping the surgical site visible for the assisting staff. In other words, the minimum adjustment in products by other manufacturers in this market segment delivers a 50% brightness, while ours already begins at 10%“, explains Stefan Zotter, Development Manager at Photonic. ”In addition, these series use a new generation of LEDs with better power efficiency. Even in high-power use scenarios, they guarantee a lifetime of 50,000 hours.

The new ATO surgery lights furnish proof of Photonic‘s technical know-how and competence in the registration of medical devices. ”With our ATO surgery lights we are also the distributor, so we consider application-relevant aspects in addition to processes in contract development and manufacturing“, stresses Zotter. For instance, Photonic conducted its own usability studies to make these products as user-friendly as possible. Furthermore, a great deal of knowledge was generated during the creation of the technical documentation
in compliance with the medical device regulation (MDR, Regulation (EU) 2017/745). ”Now all customers will benefit from this experience because, very early during development, we raise precisely those questions that will later have to be answered in front of a notified body“, Zotter explains.

Moreover, Photonic offers a comprehensive service package for the registration of medical devices, ranging from the collection and assessment of the relevant standards and guidelines to the requirements of the market, usability, risk assessment and technical documentation.