Description And Intended Purpose - Blatchford Multiflex Pyramid Ankle Instructions D'utilisation

1 Description and Intended Purpose

These Instructions for Use are intended for the practitioner and user unless otherwise stated.
The term device is used throughout these instructions for use to refer to Multiflex Pyramid Ankle.
Please read and ensure you understand these instructions, in particular all safety information and
maintenance instructions.
Application
This device is an ankle unit to be used exclusively as part of a lower limb prosthesis, intended for
a single user.
The device provides the user with comfortable multi-axial motion, which enhances stability
when used in combination with a Multiflex foot. Changeable ankle ball and snubbers provide the
ability to customize the ankle according to the user's weight and Activity Level.
Activity Level
This device is suitable for Activity Level 1–2 (weight limits apply, see Technical Data section).
As an exception to our recommendation, Activity Level 3 and Activity Level 4* users may only use
this device based upon the outcome of a prosthetic assessment.
*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 is not suitable for competitive sports events. This type of user will be better served by
a specially designed prosthesis optimized for their needs.
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