NIBRA-CS — a portable instrument for autonomic neurofunction assessment.
A diagnostic instrument that runs the full battery of cardiac autonomic reflex tests at the point of care, with no computer attached and no specialist required to run it. The client had a prototype on the bench that barely ran. We developed the firmware, the embedded software and the touchscreen product, and took it to the point where units could be built in numbers and installed in hospitals for trials.
A test that belongs in every diabetes clinic, held back by the equipment it needs.
Autonomic neuropathy is one of the earliest and most serious complications of diabetes, and one of the least often tested for. The standard work-up is a battery of cardiac reflex tests: the patient breathes, stands, strains and grips while their heart rate and blood pressure responses are recorded and scored.
Running it conventionally takes a lab, a computer, tethered instruments and someone trained to drive them, which is why it rarely happens outside a tertiary centre.
Inovocare Healthsoft Solutions set out to put the whole battery inside one portable instrument that a clinic technician could run, and had reached a prototype that proved the idea without being a product.
A clinical protocol is a timing problem before it is a software problem.
The battery is seven recordings run in a fixed order, and each one has its own sensors, its own start condition, its own stop condition and its own set of values to keep. A resting trace runs for 60 seconds. Deep breathing runs for 60. Response to standing runs for 120. The heart rate variability recording runs for 300.
The Valsalva manoeuvre is the awkward one. Recording only counts once the patient has held expiratory pressure above 40 mmHg for a continuous 15 seconds. If the pressure falls inside that window the attempt is void and the timer starts again, and when it holds, those 15 seconds stay in the record. The two blood pressure tests each break into modes of their own: supine, immediate standing and standing again after 60 seconds for postural hypotension, before and after for sustained handgrip.
All of it has to hold together on one instrument, driven by a technician who is coaching a patient at the same time, and it has to produce the same numbers as the reference equipment it is meant to replace.
The hardware concept was the client’s and partly built. Our work was everything that makes it behave like an instrument: the software on the device, the firmware talking to the sensors, and the interface the operator works with.
A bench prototype, now an instrument going into hospitals.