Vuzix Expands Reach with Device Certifications that Matter Most

Vuzix® has made a commitment to our customers to provide cutting edge technology for use in various enterprise markets. Our diligence when it comes to certifying our smart glasses gives our users the competitive edge to bring these glasses into areas like ORs, pharmaceutical facilities, clean manufacturing and research labs, and other sensitive environments. These certifications are yet another differentiator that sets Vuzix apart.
 

IP67 Dust and Water Protection
Electronic equipment can deteriorate or malfunction when water or dust enters the device. The IEC has developed the ingress protection (IP) ratings, which grade the resistance of an enclosure against the intrusion of dust or liquids. IP67 is the rating given to Vuzix M400™ and Vuzix M4000™ smart glasses and represents an extremely high level of protection against ingress. The rating means that both M-Series products have demonstrated they are dust tight and are protected against water ingress when immersed for up to 30 minutes, at a depth of 1m. When it comes to harsh work environments, the IP67 rating gives our users peace of mind that their smart glasses will continue functioning through inclement conditions.

IEC 60601 Medical Use Ratings
Vuzix continues to innovate the global healthcare industry with our heads-up, hands-free displays used in OR settings for operations and surgeries, as well as a remote training tool. Vuzix M400 and M4000 smart glasses are used dailyaround the world to provide surgical training and remote assistance for life-saving surgeries. Most recently, Vuzix collaborated with Ohana One and TeleVU to deliver smart glasses for use in Ukraine to support the assisted treatment of the wounded. Broad-based opportunities like this, for use in a medical capacity, wouldn’t be possible if it weren’t for the Vuzix M-series glasses’ growing list of IEC 60601 certifications.

IEC 60601-1-2:2014EMC

Vuzix M400 and M4000 devices are compliant with the EMC (Electromagnetic Compatibility) safety standards and have earned their IEC 60601-1-2:2014 certification. This set of strict rules, procedures, emission restrictions and immunity levels ensure the glasses emit little to no electromagnetic field. To receive this certification, the glasses were put through a series of rigorous tests and only passed after meeting certain safety and quality criteria, deeming them safe for use in medical and healthcare settings. The IEC 60601-1-2:2014 certification tells medical professionals that Vuzix M400 and M4000 smart glasses are safe in a wide array of medical and health related applications where other sensitive equipment is in use.

IEC 60601-1.2005 Essential Performance

Essential performance, IEC 60601-1:2005, is defined in the standard as “performance necessary to achieve freedom from unacceptable risk”. The essential performance must be defined by the manufacturer as part of their safety risk management process. The standard represents a change in the way medical devices are typically developed and includes heavy reliance on safety risk management and usability engineering processes. The standard focuses on safety and performance of the device, and presents a multitude of requirements, including safety risk management processes, usability engineering processes, electrical and mechanical safety testing, and labeling.

IEC 60601-1-6:2010, AMD1:2013 Usability

Regarding usability, the M-series glasses are also IEC 60601-1-6:2010, AMD1:2013 certified. This certification ensures that the glasses possess the characteristics that establish effectiveness, efficiency, and operator learnability and satisfaction. This standard is considered and tightly integrated into the entire device development process. Usability was considered early in the lifecycle to understand and design out potential usability issues prior to the products being realized in the physical domain. The application of the device, its primary operating functions, and safety labeling, all serve as inputs to the usability engineering process.

IEC 60601-1-11:2015IEC 60601-1-2:2014Home Health Ratings

The M-series glasses are also IEC 60601-1-11:2015IEC 60601-1-2:2014 certified, enabling them to be used in the home healthcare environment. This standard applies to medical equipment regardless of whether it is intended for use by an untrained individual or by trained healthcare personnel. A home healthcare environment can include any place in which a patient lives and/or places in which the patient is present (both indoor/outdoor), excluding healthcare facility environments where operators with medical training are continuously available when patients are present (i.e., hospitals, around-the-clock patient care facilities, etc.).  

With these certifications allowing Vuzix smart glasses into the OR and a wide variety of home health opportunities, health workers can safely access advanced AR capabilities while administering care, giving others access to see-what-I-see technology, allowing hands-free access to information, remote assistance, and training. Of course, technology approved for use in medical environments needs to not only have the right certifications, but also needs to be thoroughly wearable (allowing the surgeon’s hands to remain free), lightweight, and able to be worn for long periods of time. This is exactly what Vuzix enables: remote medical assistance provided at moment of need, safely and comfortably, with zero cognitive burden.

ISO 14644-1 Cleanroom rating

Vuzix M400 smart glasses have been tested for airborne particle purity and have received ISO class 2 certification. The assignment of ISO class 2, according to DIN EN ISO 14644-1, means that the Vuzix M400 devices only emit a maximum of 8 particles of size 0.1 µm and 3 particles of size 0.2 µm in one minute per cubic foot of air. If you’re manufacturing highly sensitive equipment or otherwise operating within regulated environments, this certification allows the M400 smart glasses to be used within clean room environments that are typically employed by firms in industries that include electronics, pharmaceuticals, medical devices, optics, solar and aerospace/defense.

Ruggedized and Drop Tested to 2 Meters

MIL STD 810g at 2m is an industry standard that helps demonstrate usability and robustness of a head worn device. The Vuzix M400 devices have been tested to ensure each device will still work after multiple drops in various orientations. This certification ensures that our glasses can be worn in rugged environments and still operate to the highest standard.

The list of certifications for Vuzix' M400 and M4000 smart glasses is a huge accomplishment for Vuzix and reflects our continued commitment to meet and exceed market standards.

Additional certification information is available at the product level on Vuzix.com.