Intended Use; General Safety Instructions - Össur EXOFORM DORSAL NIGHT SPLINT Instrucciones Para El Uso

ENGLISH
Medical Device

INTENDED USE

The device is intended to keep the foot/ankle in a neutral position
Indications for use
Conditions that may benefit from resting with the ankle in a neutral
position, such as:
• Plantar Fasciitis
• General Heel Pain
• Achilles Tendonitis
• Post-Static Dyskinesia
• Drop Foot
Contraindications
Plantar flexion contracture greater than 20°, diabetes, neuropathy and/or
spasticity of lower extremities.
Warnings and Cautions:
• This product is not intended for prolonged walking or weight bearing.
Any ambulation in the product should be kept to a minimum.
• Care should be taken not to overtighten the device.

GENERAL SAFETY INSTRUCTIONS

Read these instructions carefully before use. Keep them for future
reference.
Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
Never wear the device directly over an open wound.
The patient should stop using the device and contact a healthcare
professional:
• If there is a change or loss in device functionality, or if the device
shows signs of damage or wear hindering its normal functions.
• If any pain, skin irritation, or unusual reaction occurs with the use of
the device.
The device is for single patient – multiple use.
USAGE
Device Application
The device should be applied while seated.
An athletic sock may be worn on foot for additional comfort.
1. Loosen the calf strapping (A) without pulling through D-rings and
unfasten the heel strapping (B) to provide enough room to pass the
foot into and through the soft good (f ig. 1.).
2. Ensure that the device is "right side up" – the anti-slip sole (F) should
be positioned on the bottom, under the forefoot. Slide the foot into
the device until the toes reach the end of the soft good as indicated
by the toe strap (C). The toes should not extend past the toe strap
(fig. 2.).
3. Secure the device to the foot by first adjusting the foot strapping (D)
as necessary being careful to maintain a gentle and comfortable
stretch of the foot (fig. 3.). Do not over-tighten the foot strapping.
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