Description And Intended Purpose - Blatchford Blade XT Instrucciones De Uso

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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 BladeXT.
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 device is designed specifically for general sport and running.
Activity Level
This device is recommended for users that have the potential to achieve Activity Level 4 (weight
restrictions appy, see Section 9 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
This device may not be suitable for Activity Level 1 and 2 users.
Clinical Benefits
• Allows variable running speeds
• Sole plate improves perceived stability, compared to other running-specific prostheses
• Users demonstrate confidence in prosthetic loading during high activity
3
938345PK1/1-0521
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