Blatchford PK1 Echelon Instruction Manual

Blatchford PK1 Echelon

Product Information

Description and Intended Purpose

The PK1 Echelon is a prosthetic device designed for individuals with different activity levels. It allows for transfers, ambulation on level surfaces, and traversing environmental barriers. The device is suitable for limited and unlimited household ambulatory, community ambulators, and those with high impact and energy demands such as children, active adults, or athletes. The maximum user weight is 100 kg.

Contraindications

• This device may not be suitable for Activity Level 1 individual or competitive sports events. Specially-designed prostheses optimized for their needs are recommended.
• Ensure that the user has understood all instructions for use, with particular attention to the maintenance section.

Spring Set Selection

The spring set selection is based on the user’s weight and activity level:

Note : If in doubt about choosing between two categories, choose the higher rate spring set. For transfemoral users, it is suggested to select a spring set one category lower.

Safety Information

• Any changes in the performance or function of the limb should be immediately reported to your service provider.
• Always use a handrail 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. 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.

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

Activity Level 3

44-52| 53-59| 60-68| 69-77| 78-88| 89-100| 101-116| 117-125| kg User weight
---|---|---|---|---|---|---|---|---
(100-115)| (116-130)| (131-150)| (151-170)| (171-195)| (196-220)| (221-255)| (256-275)| (lbs)
1| 2| 3| 4| 5| 6| 7| 8| Foot spring set

Note:

If in doubt about 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.

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

Construction

Principal Parts

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

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.

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 them if necessary.
• Check all screws for tightness, clean and reassemble as
• 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

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 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).

Bench Alignment

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

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 roll-   over 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

Biomimetic Adjustment

NB : Carry out static alignment while ensuring the user has some means of support such as parallel bars. This is standing alignment only.

Use shift for static alignment and standing. The device should encourage some degree of self adjustment to achieve a sense of balance for the user during standing.

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.

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 Section 7.3). The springs for the Echelon foot 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

| Symptoms| Remedy
---|---|---
4.| Forefoot feels too rigid Forefoot feels too long Feels like walking up hill| 1.   Reduce dorsiflexion resistance

2.   Check A–P shift alignment;

ensure foot is not too anteriorly positioned

3.   Check distribution of plantar and dorsiflexion movement; ensure that there is sufficient dorsiflexion range

4.   Check the spring category is not too rigid for the weight and activity of the user, if so fit lower rate spring

 Assembly Instructions

WARNING : Be aware of finger trap hazard at all times.

WARNING : Use appropriate health and safety equipment at all times including extraction facilities.

Foot Shell Removal

Spring Replacement

Technical Data

Operating and

Storage Temperature Range:

| -15 ˚C to 50 ˚C

(5 ˚F to 122 ˚F)

---|---
Component Weight ( Size 26N)| 900 g (2 lb)
Activity Level:| 3
Maximum User Weight:| 125 kg (275 lb)
Proximal Alignment Attachment:| Male Pyramid (Blatchford)
Range of Hydraulic Ankle Motion

(excludes additional range of motion

provided by heel and toe springs)

| 6 degrees plantar flexion to 3 degrees dorsiflexion
Build Height:

(See diagram below)

| (sizes 22–24) 115 mm

( sizes 25–26 )   120 mm

( sizes 27–30 )   125 mm

Heel Height| 10 mm

Fitting Length

**Ordering Information

**

Order Example

Available from size 22 to size 30: EC22L1S to EC30R8S EC22L1SD to EC30R8SD (add ‘D’ for a dark tone foot shell)

• Sizes 25-28 only. For all other sizes, omit the Width field. e.g. EC25LN3S, EC22R4S, EC27RW4SD (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
Set 2| 539802S| 539811S| 539820S| 539829S
Set 3| 539803S| 539812S| 539821S| 539830S
Set 4| 539804S| 539813S| 539822S| 539831S
Set 5| 539805S| 539814S| 539823S| 539832S
Set 6| 539806S| 539815S| 539824S| 539833S
Set 7| 539807S| 539816S| 539825S| 539834S
Set 8| 539808S| 539817S| 539826S| 539835S
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

DF/PF Adjuster Key: 4.0 A/F Allen          940236

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.

Manufacturer’s Registered Address

Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH.

Trademark Acknowledgements

Echelon and Blatchford are registered trademarks of Blatchford Products Limited.

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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