Blatchford Echelon User manual

Instructions for Use
EC22L1S–EC30R8S
EC22L1SD–EC30R8SD
Echelon
Instructions for Use
Navodila za uporabo
Инструкции за употреба
Upute za uporabu
Návod na použitie
Használati útmutató
Οδηγίες χρήσης
Lietošanas pamācība
Naudojimo instrukcija
Kasutusjuhend
EN 2
SL 18
BG 34
HR 50
SK 66
HU 82
EL 98
LV 114
LT 130
ET 146
PK2

938280SPK2/1-0121
EN
2
Contents
Contents.................................................................................................................................................................2
1 Description and Intended Purpose ....................................................................................................................3
2 Safety Information....................................................................................................................................................4
3 Construction ...............................................................................................................................................................5
4 Function........................................................................................................................................................................6
5 Maintenance...............................................................................................................................................................6
6 Limitations on Use....................................................................................................................................................6
7 Bench Alignment.......................................................................................................................................................7
7.1 Static Alignment..................................................................................................................................................7
7.2 Biomimetic Alignment......................................................................................................................................8
7.3 Biomimetic Adjustment....................................................................................................................................9
7.4 Dynamic Adjustment...................................................................................................................................... 10
8 Fitting Advice........................................................................................................................................................... 11
9 Assembly Instructions .......................................................................................................................................... 12
10 Technical Data ......................................................................................................................................................... 15
11 Ordering Information ........................................................................................................................................... 16

938280SPK2/1-0121
3
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 deection. 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
benet from enhanced stability and an increase in condence 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 benet from the enhanced stability oered by Echelon, but this decision should be
made with sound and thorough justication.
*Maximum user weight 100kg 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 Benets
• 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
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 3
1 Description and Intended Purpose

938280SPK2/1-0121
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 qualied clinician.
Ensure only suitably retrotted 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
ts 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 nger trap hazard at all
times.
4
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 tting advice Section 7 to ensure satisfactory function and range of movement
Spring Set Selection
Activity
Foot
Spring set
44–52 53–59 60–68 69–77 78–88 89–100 101-116 117-125 kg
(100-115) (116-130) (131-150) (151-170) (171-195) (196-220) (221-255) (256-275) (lb)
1 2 3 4 5 6 7 8
User Weight
3

938280SPK2/1-0121
5
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)
3 Construction
Glide
Sock
Foot
Shell
Toe
Spring
Min 1
Dorsiexion
Valve Adjuster
(opposite the
plantar exion
adjuster)
DF
Heel Spring
Screws
(Loctite 243)
Plantar Flexion
Valve Adjuster
Toe Spring
Washer
Toe Spring
Screw
(Loctite 243)
PF
Carrier and
Hydraulic Body
Assembly
Heel
Spring
4
15Nm
8
35Nm
Min
Max
Min
Max

938280SPK2/1-0121
6
4 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 dorsiexion. 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.
5 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.
• 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 aect 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 stiness
• 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 aect function should be reported to their service provider (e.g. signicant 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 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 nished 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).

938280SPK2/1-0121
7
6°3°
½½
Align transfemoral devices according to tting instructions supplied with the knee.
Keep the build line between pivots as shown, using shift and/or tilt devices as necessary.
Build
Line
7 Bench Alignment
7.1 Static Alignment
Allow for users
own footwear
* *
Approx. 1/3 2/3
Tilt setting
Align limb to achieve range of motion
shown.

938280SPK2/1-0121
8
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 ne tune the ankle-foot roll-
over stiness 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 nd 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exion limit.
Falling backwards =
(Hyper-extension)
A–P shift too far forward
Falling forwards =
(Hyper-exion)
A–P shift too far back




938280SPK2/1-0121
9
7.3 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.
Check bench alignment taking
heel height into account
Ensure PF and DF valves are set as shown.
(the user must feel some movement in
the ankle)
Ask the user to stand with weight
evenly distributed between each foot
Does the user feel sufficiently stable
using minimal muscle control?
No Yes
Does the user report
a feeling of falling
forwards?
Shift the foot forwards
slightly relative to the
socket (e.g. tilt using
proximal & distal
interfaces)
Yes
No
Yes
Yes
Can the user dorsi-flex the
ankle by approx. 3°?
Adjust the angle
of the foot at the
distal pyramid
interface
Does the user report a
feeling of falling backwards?
Shift the foot backwards slightly
relative to the socket (e.g. tilt
using proximal & distal interfaces)
Proceed to
Dynamic
Adjustment
Allow user to become
accustomed to the ankle for
10 mins before carrying
out any DF/PF valve
adjustments
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.
No
}

938280SPK2/1-0121
10
Upon walking, does the user
experience foot slap?
No Yes
Adjust the Plantar
flexion valve to
reduce resistance
(counterclockwise)
No
Yes
Yes
Yes
No
No
Adjust the Plantar
flexion valve to
increase resistance
(clockwise)
Adjust the
Dorsiflexion
valve to
reduce resistance
(counterclockwise)
Does the
user find the
heel too
hard?
Transfer should be smooth.
Does the user feel as if they
are walking uphill?
Does the user feel as
if they are being
thrown forwards
through stance?
Adjust the
Dorsiflexion
valve to
increase resistance
(clockwise)
PF
1st
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 eort 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.
DF
2nd

938280SPK2/1-0121
11
8 Fitting Advice
The correct alignment (A–P position), range of motion (distribution of plantar to dorsiexion) and
adjustment of the hydraulic settings are critical in achieving a smooth roll over and correct slope
adaptation (see 6.3).
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 dorsiexion range will have a negative eect on
function and stability
Symptoms Remedy
1. Sinking at heel strike
Diculty in achieving a smooth
progression to mid stance
User feels they are walking up hill
or forefoot feels excessively long
1. Increase plantar exion resistance
2. Check A–P shift alignment; ensure foot is not too
anteriorly positioned
3. Check distribution of plantar and dorsiexion
movement; ensure that the plantar exion range
is not excessive
4. Check spring category is not too soft,
if so t a higher rate spring
2. Progression from heel strike to mid
stance is too rapid
Diculty 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 exion resistance
2. Check A–P shift alignment; ensure foot is not too
posteriorly positioned
3. Check distribution of plantar and dorsiexion
movement; ensure that there is adequate
plantar exion range
4. Check the spring category is not too high for the
weight and activity of the user, if so t 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 dorsiexion resistance
2. Check A–P shift alignment;
ensure foot is not too posteriorly positioned
3. Check distribution of plantar and dorsiexion
movement; ensure that there is not excessive
dorsiexion range
4. Check the spring category is not too soft for the
weight and activity of the user, if so t higher
rate spring

938280SPK2/1-0121
Be aware of nger trap hazard at all times.
Use appropriate health and safety equipment at all times including extraction
facilities.
1 2
12
Symptoms Remedy
4. Forefoot feels too rigid
Forefoot feels too long
Feels like walking up hill
1. Reduce dorsiexion resistance
2. Check A–P shift alignment;
ensure foot is not too anteriorly positioned
3. Check distribution of plantar and dorsiexion
movement; ensure that there is sucient
dorsiexion range
4. Check the spring category is not too rigid for the
weight and activity of the user, if so t lower rate
spring
Insert shoe horn behind heel spring. Rotate shoe horn as shown to remove shell.
9 Assembly Instructions
Foot shell removal

938280SPK2/1-0121
If a foam cosmesis is to be tted, roughen
top surface of foot shell to provide ideal
bonding surface.
3 4
5 6
87
13
Heel Spring
Re-assemble with replacement heel spring. Use
Loctite 243 (926012) and torque to 15Nm.
Remove heel spring and screws.
4
4
15Nm
Spring replacement
Cover
appropriate lines
on carrier with
permanent black
marker to leave
spring set
number showing.
Carrier
Assembly
Remove toe spring screw, replace toe. Upon
reassembly, use Loctite 243 (926012) and torque
to 35Nm. Ensure toe spring is central to the
carrier.
35Nm
8
Toe Spring
9Assembly Instructions (continued)
Lubricate toe and heel if required.
(Foot shell is pre-lubricated).
928017
Fit sock as shown.

938280SPK2/1-0121
9 10
11 12
13
14
If a cosmetic nish is required please contact a member of the Blatchford Sales Team.
Slide carrier/heel spring assembly into the foot
shell.
Use a suitable lever to encourage the heel spring
into location in the foot shell.
Ensure glide sock does not get trapped when
assembling to female pyramid part.
9 Assembly Instructions (continued)
Ensure heel spring is engaged into slot.
heel spring
location slot
Toe spring location in foot shell.

938280SPK2/1-0121
15
10mm
A
B
Fitting length
10 Technical Data
Operating and
Storage Temperature Range:
-15˚C to 50˚C
(5˚F to 122˚F)
Component Weight (Size 26N) 900g (2lb)
Activity Level: 3
Maximum User Weight: 125kg (275lb)
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 dorsiexion
Build Height:
(See diagram below)
(sizes 22–24) 115mm
(sizes 25–26) 120mm
(sizes 27–30) 125mm
Heel Height 10mm
Size A Size B
22–24 115mm 22–26 65 mm
25–26 120mm 27–28 70 mm
27–30 125mm 29–30 75 mm

938280SPK2/1-0121
16
11 Ordering Information
Order Example
DF/PF Adjuster Key: 4.0 A/F Allen 940236
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 - 539050S
28R - 539051S
29L - 539052S
29R - 539053S
30L - 539054S
30R - 539055S
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
Available from size 22 to size 30:
EC22L1S to EC30R8S
EC22L1SD to EC30R8SD
(add ‘D’ for a dark tone foot shell)
EC 25 L N 3 S
Size Side
(L/R)
Width*
(N/W)
Spring Set
Category
Sandal
Toe
*Sizes 25-27 only. For all other sizes, omit the Width eld.
e.g. EC25LN3S, EC22R4S, EC27RW4SD

938280SPK2/1-0121
Liability
The manufacturer recommends using the device only under the specied 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 classied as a class I device according to the classication rules
outlined in Annex VIII of the regulation. The EU declaration of conformity certicate is available at
the following internet address: www.blatchford.co.uk
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 eld 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 modications 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.
Medical Device Single Patient – multiple use
Manufacturer’s Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH.
Trademark Acknowledgements
Echelon and Blatchford are registered trademarks of Blatchford Products Limited.
17

938280SPK2/1-0121
Vsebina
Vsebina................................................................................................................................................................. 18
1 Opis in namen uporabe....................................................................................................................................... 19
2 Varnostne informacije .......................................................................................................................................... 20
3 Konstrukcija.............................................................................................................................................................. 21
4 Delovanje.................................................................................................................................................................. 22
5 Vzdrževanje.............................................................................................................................................................. 22
6 Omejitve uporabe.................................................................................................................................................. 22
7 Poravnava sestava.................................................................................................................................................. 23
7.1 Statična poravnava.......................................................................................................................................... 23
7.2 Biomimetična poravnava .............................................................................................................................. 24
7.3 Biomimetična prilagoditev........................................................................................................................... 25
7.4 Dinamična prilagoditev................................................................................................................................. 26
8 Nasvet za namestitev............................................................................................................................................ 27
9 Navodila za sestavljanje....................................................................................................................................... 28
10 Tehnični podatki..................................................................................................................................................... 31
11 Podatki za naročanje............................................................................................................................................. 32
SL
18

938280SPK2/1-0121
Ta navodila so predvidena za zdravnika.
Izraz pripomoček se v teh navodilih za uporabo uporablja za Echelon.
Uporaba
Pripomoček je predviden izključno kot del proteze za spodnje okončine.
Predviden je za enega uporabnika.
Pripomoček zagotavlja omejeno samodejno prilagajanje različnim podlagam, tudi po zamenjavi
obutve. Predviden je za izboljšanje telesne drže in simetrije ter zmanjšanje pritiska na ležišče.
Stopalo z zmernim povratkom energije in večosnim gibanjem gležnja. Neodvisni vzmeti na peti
in sprednjem delu stopala omogočata nekaj aksialnega pregiba. Deljeni veliki prst zagotavlja
dobro prileganje tlom.
Stopnja aktivnosti
Pripomoček je priporočen za uporabnike, ki imajo potencial doseči stopnjo aktivnosti3 in bi jim
koristila izboljšana stabilnost ter večja samozavest na neravnih površinah.
Seveda obstajajo izjeme in pri svojih priporočilih želimo upoštevati edinstvene okoliščine
vsakega posameznika. Tako lahko pripomoček koristi tudi nekaterim uporabnikom s stopnjama
aktivnosti2 in4*, ki bi jim koristila večja stabilnost, ki jo nudi stopalo Echelon, vendar pa mora
biti ta odločitev ustrezno utemeljena.
*Največja teža uporabnika je 100kg. Za izbiro sklopa vzmeti vedno uporabite naslednjo višjo
kategorijo vzmeti od prikazane v tabeli.
Kontraindikacije
Ta pripomoček ni primeren za uporabnike s stopnjo aktivnosti1 ali za vrhunske športne
prireditve, saj morajo ti uporabniki uporabljati proteze, razvite posebej za njihove potrebe.
Poskrbite, da uporabnik razume vsa navodila za uporabo in ga še posebej opozorite na poglavje
o vzdrževanju.
Klinične prednosti
• Večja razdalja od tal zmanjša tveganje padcev in spotikanja.
• Izboljšano ravnotežje zaradi samodejne poravnave.
• Izboljšana prilagoditev tlom na klančinah.
• Izboljšana kinetična simetrija pri hoji.
• Zmanjšana obremenitev na krn okončine.
• Hitrejša hoja
Ima sposobnost ali potencial za premikanje s spremenljivim korakom.
Običajno pokretna oseba, ki lahko premaga večino okoljskih ovir in morda
opravlja poklicno, terapevtsko ali zično aktivnost, ki zahteva uporabo proteze,
ki presega zgolj preprosto gibanje.
Stopnja aktivnosti 3
1 Opis in namen uporabe
19

938280SPK2/1-0121
2 Varnostne informacije
Ta opozorilni simbol poudarja pomembne varnostne informacije, ki jih je
treba natančno upoštevati.
Morebitne spremembe v delovanju
okončine, kot so npr. omejeno gibanje,
zatikajoče gibanje ali neobičajni zvoki,
je treba nemudoma javiti ponudniku
storitve.
Pri hoji po stopnicah navzdol in vedno,
ko je sicer mogoče, je treba uporabljati
držala.
Pripomoček ni primeren za ekstremne
športe, tekaške ali kolesarske dirke,
športe na ledu in snegu ter za hojo po
strminah in strmih stopnicah. Tovrstne
aktivnosti uporabnik izvaja na lastno
odgovornost. Rekreativno kolesarjenje
je sprejemljivo.
Pripomoček lahko sestavi, vzdržuje in
popravlja samo ustrezno usposobljen
zdravnik.
Poskrbeti je treba, da se za vožnjo
uporabljajo samo ustrezno predelana
vozila. Vse osebe morajo pri upravljanju
motornih vozil upoštevati veljavne
cestno-prometne predpise v svoji
državi.
Za zmanjšanje nevarnosti zdrsa in
spotika je treba vedno uporabljati
ustrezno obutev, ki se dobro prilega na
ogrodje stopala.
Po neprestani uporabi lahko postane
ohišje gležnja vroče na dotik.
Ne izpostavljajte ekstremni vročini in/
ali mrazu.
Uporabnik ne sme prilagajati ali
spreminjati nastavitve pripomočka.
Bodite pozorni, saj obstaja nevarnost,
da se vam prsti ujamejo.
Opomba:
Če ste v dvomih in ne veste, katero kategorijo izbrati, izberite sklop vzmeti z višjo
stopnjo.
Priporočila za sklope stopalnih vzmeti so prikazana za transtibialne uporabnike.
Za transfemoralne uporabnike priporočamo uporabo sklopa vzmeti eno kategorije niže.
Glejte nasvet za nameščanje v poglavju7, da zagotovite ustrezno delovanje in razpon
gibanja.
Izbor sklopa vzmeti
Aktivnost
Sklop
stopalnih
vzmeti
44–52 53–59 60–68 69–77 78–88 89–100 101–116 117–125 kg
1 2 3 4 5 6 7 8
Teža uporabnika
3
20