ThermaZone Thermal Therapy Machine, FDA Registered Medical Device
Targeted, localized, non-opioid thermal therapy without the use of ice, with consistent temperature management for both hot and cold therapy.
TT has worked in partnership with Innovative Medical Equipment for almost 10 years in a true example of providing value as an extension of their team. Providing expertise in modified power supply solutions, engineering support and understanding challenges due to changing regulations and safety standards in the medical industry.
Due to technical and supply chain problems with their existing power supply manufacturer, IME were looking for a new partner that could provide a modified-standard power supply that met the stringent medical safety and EMC regulations from minimum to maximum settings on the ThermaZone product. Specific modified requirements that could not be met by a standard power solution included:
- Customized output connector and output cable length
- Extra EMC filtering to attenuate electromagnetic energy created in the equipment
- Redesign of the no-load power behavior (burst mode) to ensure that during light loads, the system level EMC remained within specified limits
- Meets EN60601-1 medical regulation
The biggest challenge to the requirement was related to system level EMC. For conducted emissions, the power supply is the interface to the mains connection where this noise is measured and regulated. Due to the high noise being generated from the ThermaZone, the ability to design additional attenuation in the power supply’s own EMC filter was required to prevent the noise from conducting back onto the mains power lines. This was compounded by the fact that the power supply applied higher noise levels at light loads than at full loading.
What We Did
We worked hand-in-hand with the customer’s engineering team to provide technical resource and guidance. By accompanying the team to the EMC lab, we were able to characterize the offending frequencies and conditions and provide support in real-time.
We redesigned the standard ferrite core on the output cable to have multiple turns. Since inductance is related to the square of the turns, the attenuation was substantial and enough for system level approvals for world-wide use. Burst mode technology is used to decrease the operating power of a power supply during light loading. Typically, burst mode is not a standard operating mode. However, with the extremely wide operating ranges of the ThermaZone product, there were standard operating modes which caused the power supply to enter burst-mode. This caused excessive noise generation. We were able to characterize all the operating modes, and then adjust the threshold of burst mode operation of the power supply.
We designed a solution that did not affect the existing safety approvals of the power supply which saved IME considerable engineering time and cost, enabling accelerated speed to market and confidence in the solution.
“When we initially developed and launched our ThermaZone product, we viewed the external power supply as a commodity component that we could simply buy from a catalogue. Three years, and several problems later, we recognized that this component was an integral piece of the overall device. Without technical expertise on our team, we needed a partner who understood our device, its electrical componentry, and crucially the regulatory requirements associated with the production of an FDA registered medical device.
We have been doing business with TT Electronics for nearly a decade and their support and expertise has proved invaluable. Their design engineers became part of our team and helped us develop the right solution for our power needs. This is a company that will roll up their sleeves and get the job done in the design phase then deliver on their production promises. As we continue to drive innovation in our product portfolio we will no doubt continue to leverage our partnership with TT to help us deliver market leading solutions. We highly recommend you consider the same.”
Brad Pulver – President, Innovative Medical Equipment
Click here to download our ThermaZone Case Study