Medical-grade devices & systems
In Part 2
& Part 3
of our smart healthcare series, we discussed from a regulatory compliance perspective to show how a solution meets the regulations and performs with high safety standards. We wanted to wrap up this series with thorough requirements for medical-grade devices/solutions.
A medical device or solution needs to meet the following requirements,
2.Waterproof & Sealed (IP65 rating)
3.Superior Cleanliness with Fanless Design
4.IEC 60601-1 Standard (electrical & radiation safety)
Before we explain more about how to design a robust product or solution, we want to start from the scenario setting. Normally, whether a smart healthcare product applies to preventive care, digital diagnosis, or hospital & home telehealth, it needs to operate 24/7 in a compact design device. It means that the operating temperature range is wilder than common consumer use. Rugged medical-grade products are designed to operate in temperatures spanning from -40° to 70° C.
To make the product antimicrobial needs to select an antimicrobial resin mixed into the plastic that is capable of the discouraging microbe and pathogen growth. Also for cleaning needs, the product has direct sprays and splashes resisted so anyone can liberally spray onto a screen and wipe off the excess disinfectant. Bacteria can’t find crevices to hide in with a sealed front bezel, nor does the disinfectant seep into the innards of the medical-grade computer. Patients, medical staff, and the computer are protected. It’s a necessary 3-in-1 solution.
An important feature beyond the waterproof sealed bezel that medical-grade computers need is a fanless design. Not only are fans points of failure for computers, but they disperse dust, germs, and airborne bacteria that cannot be introduced into clean environments. Without fans, the products also can reach low noise.
Therefore a medical-grade device/ solution is built strong to withstand harsh conditions and rough handling above. It meets Fan-less design with IP-rating protection for superior hygiene and infection control, the anti-bacteria surface of the system chassis. As for a portable device, lightweight would be a critical requirement. To reach high-quality design requirements, mechanical and electrical teams have to consider physical, thermal, and electrical challenges. So the products/ solutions can not only achieve medical-grade but also have the versatile capability, such as multiple os porting, multiple I/O, and precision ultra low-level analog signal conversion.
Nowadays, smart healthcare devices or solutions
also meet military standard specifications for dust, shock, vibration, rain, humidity, solar radiation, altitude, and temperature extreme. It provides more assurance of performance reliability.