endolite Elite2 Manual de usuario
Elite2
EN Instructions for Use 2
FR Instructions D’Utilisation 14
DE Gebrauchsanweisung 26
IT Istruzioni per L’Uso 39
ES Instrucciones de Uso 51
EL24L1–EL30R9
EL24L1D–EL30R9D
EN
2
938223/13-0717
User weight
Foot spring
set
Impact
Activity
44–52
(100-115)
53–59
(116-130)
60–68
(131-150)
69–77
(151-170)
78–88
(171-195)
89–100
(196-220)
101-116
(221-255)
117-130
(256-285)
131-147
(286-325)
148-166
(326-365)
kg
(lb)
Low 31123456789
Mod4123456789
High423456789
Important:
For higher impact users, do not exceed the
weight limit for individual springs.
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
Application
These instructions for use are for the practitioner.
The term device is used throughout these instructions for use to refer to Elite2.
This device is to be used exclusively as part of a lower limb prosthesis.
A high-energy-return foot. The independent heel and toe springs provide axial deection. The
split toe provides good ground compliance.
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 justication.
Appropriate footwear must be worn to avoid the risk of slipping in
wet environments.
Contra-indications
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.
Intended for a single user.
Ensure that the user has understood all instructions for use, drawing particular attention to the
section regarding maintenance.
1 Description and Purpose
Spring set selection
3
938223/13-0717
When tted with springs, cover appropriate
lines on carrier with permanent black marker
to leave spring set number showing.
Note:
If in doubt choosing between two categories, choose the higher rate spring set.
Foot Spring set recommendations shown are for trans-tibial users.
For trans-femoral users we suggest selecting a spring set one category lower,
refer to tting advice Section 7 to ensure satisfactory function and range of movement
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
4
938223/13-0717
Principal parts:
• Carrier Assembly (aluminum/St. Stl./titanium)
• Heel & Toe Springs (e-Carbon)
• Spring Attachment Screws (titanium)
• Glide Sock (UHM PE)
• Foot Shell (PU)
2 Construction
Glide
Sock
Foot
Shell
Toe Spring
Carrier
Heel
Spring
Heel Spring
Screws
Toe Spring
Screw
4
15Nm
13A/F
25Nm
(cat 8&9)
4
15Nm
(cat 1–7)
Heel Wedge
5
938223/13-0717
3 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.
4 Maintenance
5 Limitations on Use
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 aect the function or
strength of the foot.
The user must be handed the user information card supplied, and be advised of the following:
• 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 qualied individual.
Cleaning
Use a damp cloth and mild soap to clean outside surfaces, do not use aggressive cleansers.
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 nished 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.
We recommend using Endolite products with this device.
0-10mm
½½
6
938223/13-0717
6 Bench Alignment
Static alignment
Setup length
With exion, adduction and abduction
properly accommodated, set the limb length
5mm longer than the sound side to allow for
compression and deection 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 10mm 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.
Saggital plane
Check for smooth transition from heel strike
to toe-o. Ensure also that when standing the
heel and toe are evenly loaded and that both
are touching the oor.
Trans-femoral alignment
Align trans-femoral components according
to tting instructions supplied with the knee,
keeping the build line relative to the foot as
shown.
Build
Line
Approx.
1/3 2/3
Allow for users
own footwear
**
7
938223/13-0717
7 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 eect of stiening the
heel spring. These can be taped in place for trial. For permanent tting, wedges should be
adhered in place by application of Loctite 424 (926104) between the lower contacting surface of
the heel and the wedge.
Heel stiness
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
diculty 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
Diculty 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
o)
3. If 1 and 2 fail, t a stier spring set
Heel too hard
• Rapid transition from heel strike
through stance phase
Diculty in controlling heel
action, foot jars into mid-stance
• Foot feels too rigid
1. Remove heel wedge (if tted)
2. Move socket posteriorly in relation to
foot
3. If 1 and 2 fail, t softer spring set
Please contact your supplier if it is not possible to achieve a smooth gait after following the advice above.
8
938223/13-0717
1
Carefully remove, with a knife, any foam cosmesis
that may be adhered to the foot shell.
2
Remove securing screws from the carrier and
pull the toe spring towards the rear of the foot.
34
Remove the toe spring to leave the carrier/heel
spring assembly alone inside the foot shell.
Rotate the carrier/heel spring assembly toward
the rear of the foot to dis-engage the spring from
it’s location in the shell.
8 Dis-assembly Instructions
5
2
4
1
3
9
938223/13-0717
9 Assembly Instructions
Assemble heel spring onto carrier, use Loctite
243 (926012) and torque to 15Nm. Use special
Allen wrench 940080, Torque spanner adaptor
940081 or 13A/F spanner 940273.
Heel
spring
Carrier
Glide
sock
Unwrap the
glide sock
onto the toe
spring
Unwrap glide sock over heel spring as shown.
Slide toe spring into position on carrier (do
not assemble bolts). Fold the glide sock neatly
around the end of the toe.
If a foam cosmesis is to be tted, roughen top
surface of foot shell to provide ideal bonding
surface.
Push toe spring forward as far as possible. Slide carrier/heel spring assembly forward into
slot in top of foot shell.
slot in
foot shell
6
11
7
9
8
10
10
938223/13-0717
9 Assembly Instructions (continued)
Slide a metal shoe horn between heel spring and
back of foot shell opening and lever the spring
down into the foot shell.
Push toe spring towards carrier. Ensure glide sock
doesn’t get trapped between the spring and
carrier. Push spring into location in shell.
Press heel spring into location in shell as shown.
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 15Nm. 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 25Nm.
Bond foam cosmesis to top surface of the foot
shell as shown using Thixox adhesive (926204)
or equivalent and shape to suit.
30mm
below heel
Toe spring
location
in foot shell
heel spring
location slot
Tabla de contenidos
Idiomas:
Manuales populares de Ayuda a la movilidad de otras marcas
Rhythm Healthcare
Rhythm Healthcare B3800F Manual de usuario
AMF-BRUNS
AMF-BRUNS PROTEKTOR Manual de usuario
Drive DeVilbiss Healthcare
Drive DeVilbiss Healthcare OTTER Manual de usuario
Rhythm Healthcare
Rhythm Healthcare C500U Manual de usuario
Lumex
Lumex RJ4200A Manual de usuario
Rebotec
Rebotec Jumbo Manual de usuario