Differences Between NDSsi Products & Consumer Grade Devices
All medical imaging devices used in operating rooms that reside within the close vicinity of the patient must meet extremely stringent electrical and mechanical safety standards. When looking at the differences between a medical-grade display vs. a consumer grade display, certain standards and regulations need to be taken into consideration as a deciding factor before making a purchasing decision, instead of just cost alone.
The FDA regulates the design control and manufacturing process used by medical device manufacturers. The FDA must give its 510K approval to sell certain medical devices.
A medical device must conform to FCC class A or B emissions and EN60601-1-2 standards.
A medical device must be certified by NRTL (Nationally Recognized Testing Labratories), such as UL, CSA, or TUV, to comply with the medical safety standard.
Electrical Safety Requirements:
Medical displays and other imaging equipment must conform to the stringent requirements of the UL 60601-1 (USA), CAN/CSA C22.2 No. 606.1 (Canada), and EN 60601-1 (Europe) standards for electrical safety, while consumer grade products are only required to meet the UL 60950 (USA), CSA 60950 (Canada), and EN 60950 (Europe) standards. Medical displays are also regulated in terms of the amount of leakage current that is allowed to flow through the device’s earth ground line. The leakage current of a Class 1 medical grade display’s power supply must not exceed 300 µA (3 x 10 – 4 amps), while a consumer grade display cannot exceed 3500 µA. Another requirement is that a medical display’s power supply must have a dielectric strength of 4000 VAC, while consumer grade displays only require a 3000 VAC dielectric strength.
Reduced Risk Of Contamination:
NDSsi surgical displays are designed to meet the EN-60529 (IPX1) liquid ingress standard, which prevents liquids and other contaminates from penetrating the front of the display’s enclosure. This is also why a sealed membrane menu keypad is used rather than push buttons. If a display is not sealed it is difficult to disinfect and contaminants can collect in small crevices and increase the potential risk of cross-contamination. To prevent the spread of airborne contaminants, boom mountable NDSsi displays utilize a fan-less cooling design. By designing systems to use alternative cooling methods, risk of cross-contamination and infection are reduced. These benefits are not required for a product to be classified as a medical device but are of key importance in reducing risk in the operating room environment.
NDSsi Video Imaging Capabilities:
Consumer grade displays cannot accept all of the many different types of video signals utilized in surgical imaging. NDSsi displays offer the capability of accepting any type of video signal, including fiber optic DVI and all HDTV formats. In order to ensure compatibility with a wide variety of different types of medical imaging equipment (endoscopic cameras, fluoroscopy & ultrasound machines, PACS systems, etc.), the video processing electronics of NDSsi medical grade displays and video routing systems are able to accommodate a very broad range of different input signal timings and resolutions. For example, no off-the-shelf consumer grade displays are capable of accepting a sync-on-green (SOG) format video signal. This specialized type of video signal, found on fluoroscopic imaging systems, can only be displayed on a medical grade type of display such as the NDSsi Radiance®. Other important features built into NDSsi visualization systems include 24 VDC power input, Multi-modality imaging, color response calibration, Picture-Perfect-Technology™, and Image-Lag-Reduction™. These features enable the extension of power cables, simultaneous viewing of multiple image sources, consistent and accurate color appearance, and smoothly displayed motion- intensive surgical images that are free of lag.
NDSsi Customization, Service, & Support:
NDSsi offers customization options to its OEM customers that are not available for consumer products, such as private labeling and revision control. In addition, NDSsi offers custom solutions that can be designed for use with certain specific imaging equipment, providing its OEM customer’s with products that are truly optimized for their endoscopic camera or other medical imaging system. NDSsi also stands behind all of its products with the best warranty, customer service, and technical product support available in the industry.
NDSsi Meets Medical Regulations, Certifications, and Approvals:
NDSsi is FDA- registered and ISO-certified with all products certified under the most stringent US, Asian, and European safety and environmental regulations.