Blatchford ECVT22L11S Hydraulic Ankle Instruction Manual

PK1
Echelon VT
Instructions for Use
ECVT22L11S to ECVT30R84S
ECVT22L11SD to ECVT30R84SD

Description and Intended Purpose

These instructions are for use by the practitioner.
The term device is used throughout this document to refer to EchelonVT .

Application
The device is to be used exclusively as part of a lower limb prosthesis.
Intended for 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. The device also includes a spring element capable of absorbing axial and rotational shocks intended to reduce sheer stresses at the residuum/socket interface.

Activity Level
This device is recommended for users that have the potential to achieve Activity Level 3 that may benefit from enhanced stability and an increase in confidence on uneven surfaces. The additional shock absorption and energy return supplied by the axial spring aims to improve comfort and performance.
There are exceptions and in our recommendation we want to allow for unique, individual circumstances. There may also be a number of users of 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 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
• Reduced loading rate on the residual limb
• Reduced back pain when twisting
• Increased walking speed

Spring Set Selection
Activity Level 3

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.

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.
The user should contact their clinician if their condition changes.
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 and Pylon Assembly (Aluminium/St. Stl./Titanium)
• Carrier Assembly (Aluminium/St. Stl.)
• Heel & Toe Springs (e-Carbon)
• Spring attachment screws (St. Stl./Titanium)
• Glide Sock (UHM PE)
• Foot shell (PU)

Function

The device comprises a hydraulic body assembly containing adjustable hydraulic valves.
The valves can be independently adjusted to increase and reduce hydraulic resistance to plantarflexion and dorsiflexion.
The proximal part of the hydraulic body assembly contains a spring component that allows the pyramid tube to deflect and/or rotate through a limited range under an axial and/or torsional load. When the load is removed the spring returns to its original position. The effect of this movement is to attenuate any shock forces that would otherwise be transmitted to the residuum/socket interface both in axial and rotational directions.
The hydraulic body assembly is connected to a carrier assembly via two pivot pins. Heel and toe springs are attached to the carrier 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:

• Check for visual defects that may affect proper function
• Clean and relubricate bearing surface. Use Sapphire Endure (928015) or equivalent PTFE loaded grease (see Section 9 Maintenance Instructions).
• 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.

Any changes in performance of this device must be reported to the practitioner. Changes in performance may include:

• Increase in ankle stiffness
• Changes in axial or torsional stiffness
• Reduced ankle support (free movement)
• Softening of springs
• Excessive play in bearings
• Any unusual noise

The user should be advised to contact their practitioner if their condition changes.
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
Avoid exposing the device to corrosive elements such as water, acids and other liquids. Also avoid abrasive environments such as those containing sand for example as these may promote premature wear.
Exclusively for use between -15˚C and 50˚C (5˚F to 122˚F).

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 dorsi-flexion 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.

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.

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.

Fitting Advice

The correct alignment (A-P position), range of motion (distribution of plantarflexion to dorsiflexion) and adjustment of the hydraulic settings are critical in achieving a smooth roll over and correct slope adaptation (see Section 7.3 Biomimetic Adjustment).
The device’s axial springs are designed to work together with the heel and toe springs to give smooth progression for most users. The axial spring controls both compressive and torsional resilience and typical axial movement should be between 3-6mm for normal walking.
The device is available with a choice of 4 axial spring rates (see Section 1 for details).
Allow the user some time to become familiar with the initial set-up.
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 will have a negative effect on function and stability:

• Incorrect spring selection
• Incorrect A-P shift alignment
• Incorrect distribution of plantarflexion and dorsiflexion range

| 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| • Increase plantarflexion resistance
• Check A-P shift alignment; ensure foot is not too anteriorly positioned
• Check distribution of plantarflexion and dorsiflexion movement; ensure that the plantar- flexion range is not excessive
• Check spring category is not too soft, if so fit 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| • Reduce plantarflexion resistance
• Check A-P shift alignment; ensure foot is not too posteriorly positioned
• Check distribution of plantarflexion and dorsiflexion movement; ensure that there is adequate plantarflexion range
• Check the spring category is not too high for the weight and activity of the patient, 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| • Increase dorsiflexion resistance
• Check A-P shift alignment; ensure foot is not too posteriorly positioned
• Check distribution of plantarflexion and dorsiflexion movement; ensure that there is not excessive dorsiflexion range
• Check the spring category is not too soft for the weight and activity of the patient, if so fit higher rate spring
4| Heel contact and progression feel OK but:
• Forefoot feels too rigid
• Forefoot feels too long
• Feels like walking up hill| • Reduce dorsiflexion resistance
• Check A-P shift alignment; ensure foot is not too anteriorly positioned
• Check distribution of plantarflexion and dorsiflexion movement; ensure that there is sufficient dorsiflexion range
• Check the spring category is not too rigid for the weight and activity of the patient, if so fit lower rate spring

Maintenance 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 Heel & Toe Spring Replacement

If a cosmetic finish is required please contact a member of the Blatchford Sales Team.

9.3 Pylon Sleeve

Clean and relubricate bearing surface.
Use Sapphire Endure (928015) or equivalent PTFE loaded grease.

9.3.1 Re-assembly
Ensure the rotation stop screw aligns with the slot in the pylon apply Loctite 243 and tighten.
Replacement Gaiter available Part No. 534003.

Technical Data

25cm – 26cm 173mm
27cm – 30cm 178mm
Heel Height:| 10mm

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: ECVT22L11S to ECVT30R84S ECVT22L11SD to ECVT30R84SD (add ‘D’ for a dark tone foot shell)

e.g. ECVT25LN12S, ECVT22R34S, ECVT27RW33SD

Spring Kits

Foot Shell (for dark add ‘D’)

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
This 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.

Trademark Acknowledgements
Echelon and Blatchford are registered trademarks of Blatchford Products Limited.

Manufacturer’s Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH, UK.

blatchford.co.uk/distributors

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 Europe GmbH
Am Prime-Parc 4
65479 Raunheim
GERMANY
Tel: +49 (0) 9221/87808-0
Fax: +49 (0) 9221/87808-60
Email: info@blatchford.de
www.blatchford.de
Email: contact@blatchford.fr
www.blatchford.fr| Endolite India Ltd.
A4 Naraina Industrial Area
Phase – 1
New Delhi
INDIA – 110028
Tel: +91 (011) 45689955
Fax: +91 (011) 25891543
Email: endolite@vsnl.com
www.endoliteindia.com
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Blatchford Europe GmbH
Am Prime-Parc 4
65479 Raunheim Germany

© Blatchford Products Limited 2019. All rights reserved.
938315SPK1/2-0922

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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