Össur PROPRIO FOOT PSX01, Instructions For Use Manual

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PROPRIO FOOT
®
The PROPRIO FOOT
®
is referred to as “the device” in the following document. This document provides important
information on the indications for use and handling of the device. It is intended for a certified prosthetist and the
user of the device. The device may only be fitted by a qualified practitioner authorized by Össur after completing
the corresponding training.
PRODUCT DESCRIPTION
The device is a microprocessor prosthetic ankle and foot system, consisting of the following components:
1. Charge connector
2. Actuator
3. Pyramid adapter
4. Power button
5. LED Indicator Ring
6. Unit serial number
7. Carbon blades
The device increases toe clearance in swing phase by raising the forefoot momentarily in mid-swing. It adjusts the
ankle angle to changing terrain, providing stable foot placement on inclined surfaces. Adjustments only occur in
swing phase when the ankle is not under load.
INDICATIONS FOR USE
The device is to be used exclusively for the exoprosthetic fitting of amputations of the lower limb.
– Unilateral trans-tibial amputation
– Bilateral trans-tibial amputation
– Unilateral trans-femoral amputation
Note: Use of the device by patients with the following conditions is subject to a case-by-case assessment, and
advanced fitting performed by a qualified Össur practitioner:
– Bilateral transfemoral amputation
– Limited residual limb control, due to e.g. unilateral hip disarticulation and lower-extremity dysmelia patients
Note: User should have sufficient control over residual limb to support device activities.
CONTRAINDICATIONS
None known.
INTENDED USE
The device is a non-invasive, reusable prosthetic device designed for single patient use.
The device supports low to moderate impact levels.
Maximum user weight is 125 kg (275 lbs.).
SPECIFICATIONS (Figure 2)
Device build heights and weights:
Size 22–24: 174 mm (67⁄8”)
Weight: 1.3 kg (2.9 lbs) Size 24, Category 2.
Size 25–27: 180 mm (71⁄16”) Weight: 1.5 kg (3.3 lbs) Size 27, Category 5.
Size 28–30: 188 mm (73⁄8”) Weight: 1.6 kg (3.5 lbs) Size 30, Category 8.
Device ankle motion range is 33°.