Blatchford PK3 EC22L1S-EC30R8S Echelon Waterproof Hydraulic Instruction Manual

: June 12, 2024
: Blatchford

Table of Contents

PK3 EC22L1S-EC30R8S Echelon Waterproof Hydraulic
Echelon
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PK3 EC22L1S-EC30R8S Echelon Waterproof Hydraulic

Echelon

Instructions for Use
EC22L1S–EC30R8S
EC22L1SD–EC30R8SD

1 Description and Intended Purpose

These instructions are for the practitioner.
The term device is used throughout these instructions for use to refer to Echelon.

Application

The device is to be used exclusively as part of a lower limb prosthesis.
Intended for a single user.
This device provides limited self-alignment of the prosthesis on varied terrain and following
footwear changes. It is intended to improve on postural sway and symmetry while easing
abnormal pressures at the socket interface. A moderate-energy-return foot with multi-axial
ankle movement. Independent heel and toe springs provides some axial deflection. The split toe
provides good ground compliance.

Activity Level

This device is recommended for users that have the potential to achieve Activity Level 3 who may
benefit from enhanced stability and an increase in confidence on uneven surfaces.
Of course there are exceptions and in our recommendation we want to allow for unique,
individual circumstances. There may also be a number of users in the Activity Levels 2 and 4*
who would benefit from the enhanced stability offered by Echelon, but this 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.

*Maximum user weight 100 kg and always use one higher spring rate category than shown
in the Spring Set Selection table.

Contraindications

This device may not be suitable for Activity Level 1 individuals or for competitive sports events,
as these types of users will be better served by a specially-designed prosthesis optimized for
their needs.
Ensure that the user has understood all instructions for use, drawing particular attention to the
section regarding maintenance.

Clinical Benefits

Increased ground clearance reduces risk of trips and falls
Improved balance through self-alignment
Improved ground compliance for slope negotiation
Improved kinetic gait symmetry
Reduced loading on the residual limb
Increased walking speed

Spring Set Selection

Note:
If in doubt choosing between two categories, choose the higher rate spring set.
Foot Spring set recommendations shown are for transtibial users.
For transfemoral users we suggest selecting a spring set one category lower,
refer to Section 8 Fitting Advice to ensure satisfactory function and range of movement

2 Safety Information

This warning symbol highlights important safety information which must be
followed carefully.

Any changes in the performance or
function of the limb e.g. restricted
movement, non-smooth motion or
unusual noises should be immediately
reported to your service provider.

Always use a hand rail when descending
stairs and at any other time if available.

The device is not suitable for extreme
sports, running or cycle racing, ice and
snow sports, extreme slopes and steps.
Any such activities undertaken are done
so completely at the users’ own risk.
Recreational cycling is acceptable.

Assembly, maintenance and repair of
the device must only be carried out by a
suitably qualified clinician.

Ensure only suitably retrofitted vehicles
are used when driving. All persons are
required to observe their respective
driving laws when operating motor vehicles.

To minimize the risk of slipping and
tripping, appropriate footwear that
fits securely onto the foot shell must be used at all times.

After continuous use the ankle casing
may become hot to the touch.
Avoid exposure to extreme heat and/ or cold.

The user must not adjust or tamper
with the setup of the device.
Be aware of finger trap hazard at all times.

3 Construction

Principal Parts

Hydraulic Body Assembly including pyramid (aluminum/St. Stl./titanium)
Carrier Assembly (aluminum/St. Stl.)
Heel & Toe Springs (e-carbon)
Spring Attachment Screws (titanium/St. Stl.)
Glide Sock (UHM PE)
Foot Shell (PU)

4 Function

Echelon comprises a hydraulic body assembly containing adjustable hydraulic valves. The
valves can be independently adjusted to increase and reduce hydraulic resistance of plantar
and dorsiflexion. The hydraulic body assembly is connected to a carrier assembly via two pivot
pins. Heel and toe springs are attached to the carrier assembly using titanium and stainless steel
screws. The foot is wrapped in a UHM PE sock which is in turn surrounded by a PU foot shell.

5 Maintenance

Maintenance must be carried out by competent personnel. It

It is recommended that the following maintenance is carried out annually:

Remove the foot shell and glide sock, check for damage or wear and replace if necessary.
Check all screws for tightness, clean and reassemble as necessary.
Visually check the heel and toe springs for signs of delamination or wear and replace if
necessary. Some surface damage may occur after a period of use, this does not affect the
function or strength of the foot.

The user should be advised:
Any changes in performance of this device must be reported to the practitioner.

Changes in performance may include:

Increase in ankle stiffness
Reduced ankle support (free movement)
Any unusual noise

The practitioner must also be informed of any changes in body weight and/or activity level.
The user should be advised that a regular visual check of the foot is recommended, signs of wear
that may affect function should be reported to their service provider (e.g. significant wear or
excessive discoloration from long term exposure to UV).

Cleaning

Use a damp cloth and mild soap to clean outside surfaces, do not use aggressive cleansers.

6 Limitations on Use

Intended Life
A local risk assessment should be carried out based upon activity and usage.

Lifting Loads
User weight and activity is governed by the stated limits.
Load carrying by the user should be based on a local risk assessment.

Environment
This device is waterproof to a maximum depth of 1 metre.
Thoroughly rinse with fresh water after use in abrasive environments such as those that may
contain sand or grit, for example, to prevent wear or damage to moving parts.
Thoroughly rinse with fresh water after use in salt or chlorinated water.

Foot products must be adequately finished to prevent water ingress into the foot shell where
possible. If water enters the foot shell, the limb should
be inverted and dried before further use.
Exclusively for use between -15 ˚C and 50 ˚C
(5 ˚F and 122 ˚F).

7 Bench Alignment

7.1 Static Alignment

Align transfemoral devices according to fitting
instructions supplied with the knee.
Keep the build line between pivots as shown,
using shift and/or tilt devices as necessary.

Tilt Setting
Align limb to achieve range of motion shown.

7.2 Biomimetic Alignment

The aim of alignment is to achieve a “balance point” while standing and set the hydraulically
damped range of motion. The aim of damping adjustment is to fine tune the ankle-foot rollover
stiffness characteristics until a comfortable gait is achieved. Due to the increased range of
motion provided by the ankle the user may experience the need for more voluntary control and
initially find the ankle disconcerting during setup. This should quickly pass upon completion of
satisfactory setup.

Ensure that the user is relaxed and not resting on the dorsiflexion limit.