Description And Intended Purpose; Contraindications - Blatchford 189128 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 to refer to the Female Shifting Pyramid Adapter.
Please read and ensure you understand these instructions, in particular all safety information and
maintenance instructions.
Application
This device is to be used exclusively for modular lower limb prostheses, intended for a single user.
The device is designed to connect an open ended Blatchford slotted chassis or top housing to a
male pyramid receiver. This allows for shifting, angular and rotational adjustment between the
two limb parts.
Features
• Lightweight, strong, titanium and aluminum construction
Activity Level
This device is suitable for Activity Levels 1-4 (weight limits apply, see Technical Data). Of course
there are exceptions and in our recommendation we want to allow for unique, individual
circumstances and any such decision should be made with sound and thorough justification.
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

There are no known contraindications if used in accordance with these instructions.
Clinical Benefit
Provides a connection between prosthetic componentry that allows some adjustment in
alignment.
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