Blatchford Elite2 Prosthetic Foot Instruction Manual

Elite2
Instructions for Use

Description and Intended Purpose

These instructions for use are for the practitioner.
The term device is used throughout these instructions for use to refer to Elite2.
Application
This device is to be used exclusively as part of a lower limb prosthesis.
Intended for a single user.
A high-energy-return foot. The independent heel and toe springs provide 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 or 4. 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 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.

Contraindications
This device might 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

• Vertical compliance for shock-absorption
• High levels of mobility for active users
• Improved prosthetic side push-off
• Increased walking speed

Spring Set Selection

Low: Daily walking and occasional sports such as golf and hiking
Moderate: Aggressive walking, frequent or daily sports such as jogging
High: Daily activities such as distance running, climbing, lifting and carrying heavy objects for vocational purposes

Important:
For higher impact users, do not exceed the weight limit for individual springs.
Note… 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.
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.

Construction

Principal Parts:

• Carrier Assembly (aluminum/stainless steel/titanium)
• Heel & Toe Springs (e-Carbon)
• Spring Attachment Screws (titanium)
• Glide Sock (UHM PE)
• Foot Shell (PU)

Function

This device comprises an e-carbon toe and independent heel spring.
Heel and toe springs are attached to the carrier using titanium 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.
We recommend the following annual maintenance:

• 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.
• Check heel and toe springs for signs of delamination or wear and replace if necessary. Some minor 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 e.g. reduced energy return or unusual noises.
• The practitioner must also be informed of any changes in body weight and/or activity level.
  If this device is used for extreme activity, the maintenance level and interval should be reviewed and if required advice and technical support sought to plan a new maintenance schedule dependent upon the  frequency and nature of the activity. This should be determined by a local risk assessment carried out by a suitably qualified individual.
  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 this device 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 units must be adequately finished to prevent water ingress into the foot shell where possible. If water enters the foot shell, it should be inverted and dried before further use.
Exclusively for use between -15 ˚C and 50 ˚C (5 ˚F to 122 ˚F) .

Bench Alignment

7.1 Static Alignment

Setup length
With flexion, adduction and abduction properly accommodated, set the limb length 5 mm longer than the sound side to allow for compression and deflection of the foot springs during gait. This should be reassessed  once the dynamic trial commences and the length adjusted accordingly.
Build Line
This should fall 10 mm anterior to the centre of the pyramid (with heel height properly accommodated). The socket should be positioned accordingly.
Dynamic Alignment
Coronal Plane
Ensure that M-L thrust is minimal by adjusting relative positions of socket and foot.
Sagittal Plane
Check for smooth transition from heel strike to toe-off. Ensure also that when standing the heel and toe are evenly loaded and that both are touching the floor.
Transfemoral Alignment
Align trans-femoral components according to fitting instructions supplied with the knee, keeping the build line relative to the foot as shown.

Fitting Advice

Spring sets are supplied as matched pairs i.e. the heel and toe spring are designed to work together to give smooth progression for most users.
Heel Wedge
A heel wedge is supplied with the foot. Fitting the wedge will have the effect of stiffening the heel spring. These can be taped in place for trial. For permanent fitting, wedges should be adhered in place by application  of Loctite 424 (926104) between the lower contacting surface of the heel and the wedge.
Heel Stiffness
Progression throughout the stance phase should be smooth; heel function is key to this process:

• Too soft a heel or load line excessively posterior will result in sinking at heel strike and difficulty in getting over the toe.
• Too hard a heel or load line excessively anterior will result in a rapid progression through mid-stance or jarring at heel strike.

| Symptoms| Remedy
---|---|---
Heel too soft| • Sinking at heel strike
• Difficulty climbing over the
toe (toe feels too hard)| 1. Add heel wedge
2. Move socket anteriorly in relation to the foot (excess  movement may result in drop off )
3. If 1 and 2 fail, fit a stiffer spring set
Heel too hard| • Rapid transition from heel strike through stance phase
• Difficulty in controlling heel action, foot jars into instance
• Foot feels too rigid| 1. Remove heel wedge (if fitted)
2. Move socket posteriorly in relation to foot
3. If 1 and 2 fail, fit softer spring set
Toe/ Blade too soft| • Rapid progression through mid-stance.
• ‘Drop off’ at higher Activity Levels| 1. Move socket posteriorly in relation to foot
2. Plantarflex foot slightly – note: some re-alignment may  be required

Please contact your supplier if it is not possible to achieve a smooth gait after following the advice above.

Dis-assembly Instructions

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

Assembly Instructions

Technical Data

Operating and
Storage Temperature Range:| 15 ˚C to 50 ˚C
(5 ˚F to 122 ˚F)
---|---
Component Weight (size 26):| 680 g (1 lb 7 oz)
Activity Level:| 3–4
Maximum User Weight:| 166 kg (365 lb)
Proximal Alignment Attachment:| Male Pyramid (Blatchford)
Range of Adjustment:| ±7 ° Angular
Build Height:
(See diagram below)|  130 mm
Heel Height:| 10 mm

Fitting Length

Ordering Information

Order Example

e.g. EL25LN3S
*Sizes 25–28 only. For all other sizes, omit the Width field.
Available from size 22 to size 30:
EL22L1S to EL30R9S
EL22L1SD to EL30R9SD

Spring Kit

Foot Shell

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 licences 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
Elite Foot 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 Europe GmbH
Am Prime-Parc 4
65479 Raunheim Germany

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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