Description And Intended Purpose - Blatchford Female Mini Pyramid Tube Instrucciones De Uso

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 the Female Mini Pyramid
Tube Adaptor.
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.
The device connects a Male Mini Pyramid to a 25/30 mm diameter tube and allows for angular
and rotational adjustment.
Intended for a single user only.
Activity Level
This device is suitable for activity levels 1 to 4; weight limits apply, see Technical Data Section 7.
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 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 Benefits
• Provides a connection point from a pylon tube to other prosthetic componentry.
• Allows connection of Blatchford Child Pyramid devices.
3
938373PK1/1-0521