Use Instructions

Orpyx

SI – Instructions for Use

Version 1.0 – August 2019

Page 5 of 26

1. Orpyx

SI Sensory Insoles

The Orpyx

SI sensory insole system is designed to help patients at risk of foot ulceration. The system

consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly

communicate with a display application running on a smartphone or companion device. In addition to

pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by

the device and sent to the cloud for remote monitoring purposes.

INCLUDED IN PURCHASE:

• Orpyx

SI Sensory Insoles

(Left and Right)

• USB Cable

• Instructions for Use Manual

• Power Adapter

A. INDICATIONS & INTENDED USE

Orpyx SI Sensory Insoles are custom insoles embedded with powered limb overload warning

technology intended for monitoring physiologic parameters, including plantar pressure, tracking

movements and temperature. It provides the user with real-time, individualized cues for pressure

offloading. It is intended to act as an adjunct to standard foot care, not a replacement.

Orpyx SI sensory insoles are designed for use throughout everyday activities.

When using Orpyx SI sensory insoles with an active foot ulcer, please notify your healthcare

professional.

The custom insoles are made specific to an individual’s foot and are not transferable to

another user.

Use of Orpyx SI sensory insoles does not eliminate the need for regular diabetic foot care as

advised by a healthcare professional.

Users should continue to consult their healthcare provider in addition to checking feet daily

and wearing proper footwear. In the event there is any evidence of tissue breakdown, consult

your healthcare provider immediately.

B. CONTRAINDICATIONS

There are no known contraindications for the Orpyx SI sensory insoles at this time.