Blatchford Elite2 EL22L1S-EL30R9S Lightweight Prosthetic Foot Instruction Manual

: June 12, 2024
: Blatchford

Elite2 EL22L1S-EL30R9S Lightweight Prosthetic Foot

Elite2

Instructions for Use
EL22L1S–EL30R9S
EL22L1SD–EL30R9SD

1 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 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.

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.

3 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)

4 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.

5 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.

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 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.

7 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 re-assessed 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.

Allow for users own footwear

*Approximate ratio

8 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 mid

stance

• 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.

9 938223SPK2/2-0422

9 Dis-assembly Instructions

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

Be aware of finger trap hazard at all times.

1

Carefully remove, with a knife, any foam cosmesis that may be adhered to the foot shell.

2

2. Remove securing screws from the carrier and pull the toe spring towards the rear of the foot.

3

3. Rotate the carrier/heel spring assembly toward

4

4.Remove the toe spring to leave the carrier/heel spring assembly alone inside the foot shell.

10

the rear of the foot to dis-engage the spring from it’s location in the shell.

938223SPK2/2-0422

10 Assembly Instructions

1.

Assemble heel spring onto carrier as shown.

2.

Use special Allen wrench 940080, Torque spanner
adaptor 940081 or 13A/F spanner 940273. Use
Loctite 243 (926012) and torque to 15 Nm.

15Nm or

13A/F

Assemble heel spring onto carrier as shown.

Use special Allen wrench 940080, Torque spanner adaptor 940081 or 13A/F spanner 940273. Use Loctite 243 (926012) and torque to 15Nm.

Attach the toe spring to the carrier using Loctite 243 (926012) on the bolts.
1. For spring rates 1 to 7 use 4 A/F Allen wrench and torque to 15 Nm. Do not use external hex, this is
reserved for loosening the bolt, if required.
2. For spring rates 8 and 9 use 13 A/F spanner and torque to 25 Nm.

Ensure correct spring set number is marked on left side of carrier. Use black marker to cover
unwanted segments.

Fit glide sock onto the toe spring, heel spring and carrier assembly as shown.

6.

If a foam cosmesis is to be fitted, roughen top surface of foot shell to provide ideal bonding surface.

Toe spring location in foot shell

Slide whole assembly into foot shell. Ensure
correct fit into toe spring slot.

Slide a metal shoe horn between heel spring and back of foot shell opening and lever the spring
down into the foot shell.

Press heel spring into location in shell as shown.
The shoe horn should be located approx. 30 mm
below top surface of foot shell

Ensure heel spring’s correct fit into location slot in foot shell.

30mm

below heel

Press heel spring into location in shell as shown.

heel spring location slot

The shoe horn should be located approx. 30 mm below top surface of foot shell

Bond foam cosmesis to top surface of the foot shell as shown using Thixofix adhesive (926204) or equivalent and shape to suit.

11 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

12 Ordering Information

Order Example Available from size 22 to size 30:

EL

|

25

|

L

|

N

|

3

|

S

---|---|---|---|---|---

EL22L1S to EL30R9S

Size Side

(L/R)

e.g. EL25LN3S

Width* (N/W)

Spring Set Category

Sandal Toe

EL22L1SD to EL30R9SD (add ‘D’ for a dark tone foot shell)

*Sizes 25–28 only. For all other sizes, omit the Width field.

Spring Kit

|

Foot Size

---|---

22-24

|

25–26

|

27–28

|

29–30

Set 1

|

539701S

|

539710S

|

539719S

|

Special order

Set 2

|

539702S

|

539711S

|

539720S

|

Special order

Set 3

|

539703S

|

539712S

|

539721S

|

539730S

Set 4

|

539704S

|

539713S

|

539722S

|

539731S

Set 5

|

539705S

|

539714S

|

539723S

|

539732S

Set 6

|

539706S

|

539715S

|

539724S

|

539733S

Set 7

|

539707S

|

539716S

|

539725S

|

539734S

Set 8

|

539708S

|

539717S

|

539726S

|

539735S

Set 9

|

539718S

|

539727S

|

539736S

Foot Shell (For dark add ‘D’)

Size/Side

|

Narrow

|

Wide

---|---|---

22L

|

539038S

|

–

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

27R

|

539049SN

|

539049SW

28L

|

539050SN

|

539050SW

28R

|

539051SN

|

539051SW

29L

|

–

|

539052S

29R

|

–

|

539053S

30L

|

–

|

539054S

30R

|

–

|

539055S

Glide Sock

Sizes 22-24

|

531011

---|---

Sizes 25-30

|

532811

14 938223SPK2/2-0422

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.co.uk/distributors

Blatchford Inc.
1031 Byers Road
Miamisburg
Ohio 45342
USA
Tel: +1 (0) 800 548 3534
Fax: +1 (0) 800 929 3636
Email: info@blatchfordus.com
www.blatchfordus.com

Blatchford Europe GmbHAm Prime-Parc 465479 Raunheim Germany