AERO

Regulatory &
Quality.

AERO is tested to IEC 60601, third edition, comes in IP68 sealed configurations, and is UL tested. Because it has already been reviewed across multiple OEMs’ FDA submissions, it is familiar to reviewers, which can help smooth your own regulatory path.  

What the field tells us.

The customer feedback has been anonymous and, more tellingly, behavioral. Adoption was slow at first, then grew as OEMs saw the value of starting from a proven base instead of a clean sheet. The teams that adopted AERO have gone on to expand it onto additional consoles, which is the clearest signal a control has earned its place in the system. 

What it comes down to, by stakeholder: 

For OEM Engineers:

A configurable base that fits the application
without a clean sheet design.

For Quality and Regulatory:

A device reviewers already know,
tested to 60601 and sealed to IP68.

For the Surgeon:

A control that is easy to clean and
comfortable to use through a long procedure.

For the OEM’s Bottom Line:

Simpler cord handling and serviceable parts. 

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