Ossur FORMFIT WALKER - EN | Instructions for Use

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ENGLISH
SYMBOLS
Medical Device
INTENDED USE
The device is intended for immobilization of the foot and ankle
Indications for use
High Top:
• Foot and ankle conditions that may benefit from motion restriction,
such as:
– Grade  and  ankle sprains
– Stable fractures
– Soft tissue injuries
– Post-operative, trauma or rehab use
Low Top:
• Foot and ankle conditions that may benefit from motion restriction,
such as:
– Stable foot fractures
– Soft tissue injuries
– Post-operative, trauma or rehab use
No known contraindications.
Warnings and Cautions:
Do not remove the device unless instructed by a healthcare professional.
• Regular healthcare professional supervision is recommended for
patients with peripheral vascular disease, neuropathy, and sensitive
skin.
• This device should not be applied on patients who are not able to
communicate discomfort.
• Patient should use caution when walking on slippery or wet surfaces
to avoid injury.
• Ensure the patient performs circulation checks. If a loss of circulation
is felt, or if the walker feels too tight, release contact closure straps
and adjust to a comfortable level. If discomfort continues, the patient
should contact their healthcare professional immediately.
• The use of the device may increase the risk of deep vein thrombosis
and pulmonary embolism.
• Care should be taken not to overtighten the device.
• Open wounds or damaged skin should be covered with a bandage or
other appropriate covering to prevent direct contact between the wound
and device.
Air version only:
• Ensure not to overinflate the air chamber.
• Over inflation of air chamber may cause skin compromise in patients
with diabetic neuropathy. Deflate air chamber to reduce compression
with patients reporting discomfort or showing skin discoloration.
• Ensure patient performs circulation checks. If a loss of circulation is
felt, or if the device feels too tight, deflate the air chamber to reduce
compression to a comfortable level. If discomfort continues, the
patient should contact their healthcare professional immediately.