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.

The applicable safety standards for an MDD Class I display are IEC/EN

60601-1:1990 along with Amendments 1 and 2. To help the medical device designer evaluate the suitability of these displays, Planar has also conducted EMC testing to IEC 60601-1-2 as it can be applied. The display with its power supply alone does not represent a functional medical device. Hence, Planar configured a minimal operating system to exercise the display. The resulting data are made available to interested parties.

This is informative data, not certification data. Certification data must be obtained by the device or system integrator according to Article 12 of the MDD titled “Particular procedure for systems and procedure packs.” Paragraph 2 clearly outlines the device or system integrator’s responsibility in this matter.

In summary, Planar Systems, Inc. is CE-marking these displays under the Medical Device Directive, which establishes compliance to the basic medical safety standards. However, EMC compliance can only be accomplished in the configured medical device or system and is the responsibility of the device or system manufacturer. Planar has the necessary documentation such as IEC 60601-1 notified body and other third-party test reports and certifications, a risk/hazard analysis, an essential requirements checklist, and the Planar International Electrotechnical Commission (IEC) declaration of conformity.

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Planar C3i/EX manual

C3i/EX specifications

The Planar C3i/EX is a state-of-the-art display solution designed for demanding operational environments. Its robust features and advanced technologies make it a favorite among professionals in various sectors, including military, aviation, security, and public safety.

At the heart of the Planar C3i/EX system lies its ultra-high-definition display capabilities, ensuring that crucial information is presented with clarity and precision. With a resolution that often exceeds standard HD, users benefit from enhanced image quality that allows for better visibility of intricate details—vital in mission-critical situations.

One of the standout features of the C3i/EX is its modular design, enabling seamless integration into existing operation centers. Its flexibility allows for the setup of multiple configurations, accommodating various screen sizes and orientations. This adaptability is particularly beneficial for organizations that require specific visual layouts, whether for fixed installations or mobile command units.

The C3i/EX incorporates innovative technologies such as anti-glare and anti-reflective coatings, ensuring optimal performance under diverse lighting conditions. This feature is essential for users who may operate in environments with bright lights or direct sunlight, where screen visibility can become compromised.

Another important characteristic is the Planar C3i/EX's durability. Designed to withstand harsh conditions, the display is built with rugged materials that protect against dust, moisture, and physical shock. This ruggedization ensures that the display can endure the stresses of field operations, making it a reliable component in critical scenarios.

Additionally, the C3i/EX boasts significant connectivity options. With HDMI, DisplayPort, and various network capabilities, users can easily integrate the display with a multitude of sources, facilitating efficient information sharing and collaboration. This feature is particularly advantageous in command centers where rapid data exchange is crucial.

Furthermore, the Planar C3i/EX is engineered with user comfort in mind. It supports wide viewing angles, allowing multiple personnel to view the display clearly from different positions. This element enhances teamwork, as team members can actively engage with the information being presented.

In conclusion, the Planar C3i/EX is a premier display solution that combines high-resolution clarity, modular design, rugged durability, and versatile connectivity. It is specifically tailored for professionals who require reliable and efficient visualization tools in challenging operational environments. With its array of advanced features and technologies, the C3i/EX stands out as an essential resource for contemporary mission-critical applications.