Blatchford EchelonER Hydraulic Ankle with Extended Range Instruction Manual

EchelonER
Instructions for Use
ECER22L1S–ECER30R8S
ECER22L1SD–ECER30R8SD

Description and Intended Purpose

These instructions are for the practitioner.
The term device is used throughout these instructions for use to refer to EchelonER.
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 allows the ankle to adjust to a moderate variation in heel heights. It is intended to improve on postural sway and symmetry while  easing abnormal pressures at the socket interface. A moderate-energyreturn 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 the device, 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, users with poor balance, or users who take part in competitive sports events, as these types of users will be better served by a specially-designed  prosthesis optimized for their needs. Users who require additional support when standing, e.g. bilaterals, may benefit from an ankle with a reduced range of DF movement–see Bench Alignment section, or an ankle  with a standing mode lock.
Due to the large potential range of ankle movement, it is essential to ensure that the user has understood all instructions for use, drawing particular attention to the sections regarding safety and 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
Activity Level 3

Notes:
If in doubt choosing between two categories, choose the higher rate spring set.
Foot Spring set recommendations shown are for transstadial 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.

Safety Information

This warning symbol highlights important safety information which must be followed carefully.
Ensure only suitably retrofitted vehicles are used when driving. All persons are required to observe their respective driving laws when operating motor vehicles.
Do not ascend /descend ladders, the added range of DF/PF motion may cause the foot to slip.
Due to the amount of ankle movement available with this device, take extra care when operating any form of machinery.
Be aware of finger trap hazard at all times. It is recommended that a flexible cosmetic cover is used to minimise risk.

Always use a hand rail when descending stairs and at any other time if available.
Following activities which result in a high degree of self alignment e.g. after sitting or stairs descent, weight should be applied in a neutral position to restore the foot to its optimal standing position.
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.
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.
To minimise the risk of slipping and tripping, appropriate footwear that fits securely onto the footshell 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, which may affect ankle stiffness.
The user must not adjust or tamper with the setup of the device.
The user should contact their clinician if their condition changes.

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)

Function

This device 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.

Maintenance

Maintenance must be carried out by competent personnel.
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.
• Clean and check moving parts for signs of damage due to ingress of debris.
• Check all screws for tightness (see Construction section), 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.

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 meter.
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.
It is recommended that only Blatchford products be used in conjunction with the device.
Exclusively for use between -15 ˚C and 50 ˚C (5 ˚F and 122 ˚F).

Bench Alignment

7.1 Static Alignment

Align transfemoral devices according to fitting instructions supplied with the knee.
Ensure knee components are setup to provide adequate stability under all circumstances at the completion of alignment and adjustment of the device.
Keep the build line between pivots as shown, using shift and/or tilt devices as necessary.
Nominal Tilt Setting
Align limb to achieve 25° range of motion as shown.

The ankle may be aligned with a reduced DF range of 3° to suit users who require additional  support when standing e.g. bilaterals. Note that this will result in the PF range increasingto 22°.

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.

7.3 Biomimetic Adjustment
Note…Carry out static alignment while ensuring the user has some means of support such as parallel bars. This is standing alignment only.

7.4 Dynamic Adjustment
Adjustment of the Hydraulic Valves
The user should experience the ankle moving with the body through the gait cycle. There should be no effort exerted by the user to overcome the hydraulic resistance of the ankle.

Guidance
Following dynamic adjustment, trial the foot/ankle on ramps and stairs. Ensure the user is comfortable with the kind of terrain he/she may normally be expected to encounter. If the user reports any issues with  comfort, usability or range of movement of the ankle, adjust accordingly. When descending stairs, in order to prevent the foot plantar flexing excessively, the foot should be positioned such that the edge of the step  corresponds to the middle of the device.

Fitting Advice

The correct alignment (A–P position), range of motion (distribution of plantar to dorsiflexion) and adjustment of the hydraulic settings are critical in achieving a smooth roll over and correct slope adaptation (see  Biomimetic Adjustment section).
The springs for this device will be supplied assembled with heel and toe springs of the same category. If after following the instructions below you still have problems with the function please contact the sales team in  your area for advice.
Any of the following:

• Incorrect spring selection
• Incorrect A–P shift alignment
• Incorrect distribution of plantar and dorsiflexion range will have a negative effect on function and stability

| Symptoms| Remedy
---|---|---
1.| Sinking at heel strike
Difficulty in achieving a smooth progression to mid stance
User feels they are walking up hill or forefoot feels excessively long| 1.Increase plantar flexion resistance
2.Check A-P shift alignment ensure foot is not too anteriorly positioned
3.Check distribution of plantar and dorsiflexion movement ensure that the plantar flexion range is not excessive
4.Check spring category is not too soft, if so fit a higher rate spring
2,| Progression from heel strike to mid stance is too rapid
Difficulty in controlling the energy return from the foot at the heel strike (reduced knee stability)
User feels heel is too hard, fore foot is too short| 1.Reduce plantar flexion resistance
2.Check A-P shift alignment; ensure foot is not too posteriorly positioned
3.Check distribution of plantar and dorsiflexion movement ensure that there is adequate plantar flexion range
4.Check the spring category is not too high for the weight and activity of the user, if so fit lower rate spring
3.| Heel contact and progression feel OK but:
Forefoot feels too soft Forefoot feels too short
User feels they are walking down hill, possibly with reduced knee stability
Lack of energy return| 1.Increase dorsiflexion resistance
2.Check A-P shift alignment; ensure foot is not too posteriorly positioned
3.Check distribution of plantar and dorsiflexion movement ensure that there is not excessive dorsiflexion range
4.Check the spring category is not too soft for the weight and activity of the user, if so fit higher rate spring

Assembly Instructions

Be aware of finger trap hazard at all times.
Use appropriate health and safety equipment at all times including extraction facilities.

9.1 Foot Shell Removal

9.2 Spring Replacement

Technical Data

Range of Hydraulic Ankle Motion
(excludes additional range of motion
provided by heel and toe springs)| 19 degrees plantar flexion
to 6 degrees dorsiflexion
Build Height:
(See diagram below)| (sizes 22–24)    142 mm
(sizes 25–26)    147 mm
(sizes 27–30)    152 mm
Heel Height| 10 mm

Fitting Length

Ordering Information

Order Example

*Sizes 25–28 only. For all other sizes, omit the Width field.
Available from size 22 to size 30:
ECER22L1S to ECER30R8S
ECER22L1SD to ECER30R8SD (add ‘D’ for a dark tone foot shell)

Spring Kits

Rate| Foot sizes
Small (S)| Medium (M)| Large (L)| Extra Large (XL)
22-24| 25-26| 27-28| 29-30
Set 1| 539801S| 539810S| 539819S| 539828S
Sett| 539802S| 539811S| 539820S| 539829S
Set 3| 539803S| 539812S| 5398215| 5398305
Set 4| 5398045| 5398135| 5398225| 5398315
Set 5| 5398055| 5398145| 5398235| 5398325
Set 6| 5398065| 5398155| 5398245| 539833S
Set 7| 5398075| 5398165| 5398255| 5398345
Set 8| 5398085| 5398175| 5398265| 5398355
Foot Shell (for dark add ‘D’)| Glide Sock
---|---
Size/Side| Narrow| Wide
22L| 539038S| | 531011
22R| 539039S|
23L| 539040S|
23R| 539041S|
24L| 539042S|
24R| 539043S|
25L| 539044SN| 539044SW
25R| 539045SN| 539045SW
26L| 539046SN| 539046SW
26R| 539047SN| 539047SW
27L| 539048SN| 539048SW| 532811
27R| 539049SN| 539049SW
28L| 539050SN| 539050SW
28R| 539051SN| 539051SW
29L| | 539052S
29R| | 539053S
30L| | 539054S
30R| | 539055S

Liability
The manufacturer recommends using the device only under the specified conditions and for the intended purposes. The device must be maintained according to the instructions for use supplied with the device. The manufacturer is not liable for any adverse outcome caused by any component combinations that were not authorized by them.
CE Conformity
This product meets the requirements of the European Regulation EU 2017/745 for medical devices. This product has been classified as a class I device according to the classification rules outlined in Annex VIII of the regulation. The EU declaration of conformity certificate is available at the following internet address: www.blatchford.co.uk

| Medical Device
---|---
| Single Patient – multiple use

Compatibility
Combination with Blatchford branded products is approved based on testing in accordance with relevant standards and the MDR including structural test, dimensional compatibility and monitored field  performance.
Combination with alternative CE marked products must be carried out in view of a documented local risk assessment carried out by a Practitioner.
Warranty
The device is warranted for 36 months – foot shell 12 months – glide sock 3 months. The user should be aware that changes or modifications not expressly approved could void the warranty, operating licenses and  exemptions. See Blatchford website for the current full warranty statement.
Reporting of Serious Incidents
In the unlikely event of a serious incident occurring in relation to this device it should be reported to the manufacturer and your national competent authority.
Environmental Aspects
Where possible the components should be recycled in accordance with local waste handling regulations.
Retaining the Packaging Label
You are advised to keep the packaging label as a record of the device supplied. mpatibility Combination with Blatchford branded products is approved based on testing in accordance with relevant standards and the  MDR including structural test, dimensional compatibility and monitored field performance.
Combination with alternative CE marked products must be carried out in view of a documented local risk assessment carried out by a Practitioner.
Warranty
The device is warranted for 36 months – foot shell 12 months – glide sock 3 months. The user should be aware that changes or modifications not expressly approved could void the warranty, operating licenses and  exemptions. See Blatchford website for the current full warranty statement.
Reporting of Serious Incidents
In the unlikely event of a serious incident occurring in relation to this device it should be reported to the manufacturer and your national competent authority.
Environmental Aspects
Where possible the components should be recycled in accordance with local waste handling regulations.
Retaining the Packaging Label
You are advised to keep the packaging label as a record of the device supplied.
Manufacturer’s Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH.
Trademark Acknowledgements
Echelon and Blatchford are registered trademarks of Blatchford Products Limited.

Blatchford Products Ltd.
Unit D Antura
Kingsland Business Park
Basingstoke
RG24 8PZ
UNITED KINGDOM
Tel: +44 (0) 1256 316600
Fax: +44 (0) 1256 316710
Email: customer.service@blatchford.co.uk
www.blatchford.co.uk
© Blatchford Products Limited 2022. All rights reserved.

References

• The Most Advanced Lower Limb Prosthetics in the World
• The Most Advanced Lower Limb Prosthetics in the World
• Blatchford Deutschland - Prothetik für die untere Extremität
• Blatchford France | Mobility Made Possible
• The Most Advanced Lower Limb Prosthetics in the World
• endoliteindia.com
• Ortopediske hjelpemidler | Ortopro AS

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