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 BK Top Housing
(BK=Below Knee).
Please read and ensure you understand all instructions for use, in particular all safety information
and maintenance instructions.
Application
The Device is designed for use exclusively as part of a lower limb prosthesis.
This device is a 30 mm tube clamp connector allowing connection of Blatchford single bolt
devices to a 30 mm tube.
Once the secondary device is attached there will be facility for:
• ± 5 mm horizontal shift
• Rotation (up to 360°)
Intended for single user only.
Activity Level
This device is suitable for activity levels 1 to 3; weight limits apply, see Technical Data, Section 9.
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.
Contraindications
This device is not suitable for immersion.
Maximum user weights apply, see Technical Data Section.
Clinical Benefits
• Allows connection of single bolt devices to 30mm tube
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