Regulatory Compliance

Canada, European Union, United States

This display has been tested and found to comply with IEC/EN 60601-1 and IEC/EN 60601-1-2 standards, and is certified to meet medical standard C22.2 No. 601.1-M1990 (C US Mark).

The medical display, in addition to meeting medical

requirements, has been tested and found to comply with the limits for Federal Communications Commission (FCC) Class B computing devices in a typically configured system since many medical offices are located in residential areas. It is the system integrator’s responsibility to test and ensure that the entire system complies with applicable electromagnetic compatibility (EMC) laws.

Planar Systems, Inc. has made great efforts to support the medical device industry, in particular, medical device manufacturers and medical device system integrators. We offer state-of-the-art color displays that are compliant with worldwide accepted medical device safety standards, and for the European market, CE-marked displays based on compliance with counsel directive 93/42/EEC—commonly referred to as the Medical Device Directive (MDD). The following summarizes our qualification of these displays as it relates to compliance with the MDD.

The European Medical Device Directive requires that the intended use of the device be defined. The intended use of these displays is “to display alphanumeric, graphic, and image data as inputted from any type of medical device.” These displays do not provide a measurement function in any way, and it is the device and systems manufacturer’s responsibility to verify its function in the integrated device or system.

The display was classified as required by the MDD according to Annex IX of the directive and the medical device (MEDDEV) guidance available at the time of classification. Because the display uses electrical energy and has no direct patient connections and—by itself—no medical utility, the display is classified according to Rule 12 as an MDD Class I device, component, or accessory. The MDD states that manufacturers of Class I medical devices

or accessories shall satisfy the requirements in regard to design and manufacturing controls, that is, the applicable assessment route to be used for CE-marking under the MDD, and it shall carry the CE mark according to Annex XII of the directive, with no notified body annotation.

E2C specifications

The Planar E2C is a leading-edge display technology designed to meet the increasing demand for high-quality visual performance in various applications, including corporate environments, education, retail, and control rooms. This innovative solution is characterized by its exceptional picture quality, versatility, and advanced features that cater to the needs of users across multiple sectors.

One of the standout features of the Planar E2C is its ultra-high-definition resolution. With 4K capabilities, the display produces stunningly clear images and vibrant colors, ensuring that content is presented with remarkable detail and realism. This level of clarity enhances viewer engagement, making it an ideal choice for environments where visuals play a crucial role, such as digital signage and video walls.

In addition to its visual quality, the Planar E2C boasts an impressive modular design. This feature allows for easy configuration and customization based on specific project requirements. The modular design enables users to create large video walls composed of various screen sizes while maintaining seamless image continuity across the display. This flexibility is essential for organizations seeking to scale their visual solutions over time or adapt to different usage scenarios.

The Planar E2C is built with advanced technologies that enhance its operational efficiency and user-friendliness. Integrated video processing simplifies connectivity and management of multiple sources, allowing users to easily switch between different inputs without interruption. The display also incorporates advanced color calibration technology, ensuring that colors are consistently accurate and uniform across all tiles, which is crucial for maintaining a professional appearance in presentation settings.

Durability is another key characteristic of the Planar E2C. Designed for both indoor and outdoor environments, the display is constructed with robust materials that provide protection against wear, tear, and environmental factors. This durability makes it particularly suitable for high-traffic areas and installations that demand long-term reliability.

Finally, the Planar E2C supports diverse mounting options and installation configurations. Whether it is wall-mounted, suspended, or integrated into custom setups, the display’s design caters to various architectural needs. This versatility, combined with its high performance, makes the Planar E2C a sought-after solution for businesses and organizations looking to elevate their visual communication standards. In summary, the Planar E2C stands out as a powerful tool for creating immersive and impactful visual experiences in an array of professional settings.