Description And Intended Purpose; Contraindications - Blatchford Multiflex Standard Instructions D'utilisation

1 Description and Intended Purpose

These Instructions for Use are intended for use by the practitioner and user unless otherwise
stated.
The term device is used throughout these instructions for use to refer to Multiflex feet.
Please read and ensure you understand all instructions for use, in particular all safety information
and maintenance instructions.
Application
This device is to be used exclusively as part of a lower limb prosthesis.
Intended for a single user.
This combination provides the user with multi-axial motion when used in conjunction with a
multiflex ankle, which enhances stability. The low profile design with sandal toe gives the foot a
more natural appearance.
Activity Level
This device is recommended for Activity Level 1–2 users.
There are exceptions to our recommendations and we want to allow for individual circumstances.
There may be Activity Level 3–4* users who may benefit from this product, but this decision
should be made with sound and thorough justification.
*Maximum user weight: 100 kg (220 lb).
Activity Level 1
Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed
cadence. Typical of the limited and unlimited household ambulator.
Activity Level 2
Has the ability or potential for ambulation with the ability to traverse low level environmental barriers
such as, curbs, stairs or uneven surfaces. Typical of the limited community ambulator.
Activity Level 3
Has the ability or potential for ambulation with variable cadence.
Typical of the community ambulator who has the ability to traverse most environmental barriers and
may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond
simple locomotion.
Activity Level 4
Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting
high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or
athlete.

Contraindications

This device may not be suitable for use in competitive sports events. This type of user may be
better served by a specially designed prosthesis optimized for their needs.
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