embreis eWalk E7W Series User manual

eWalk
INSTRUCTIONS FOR USE

eWalk
2
Introduction
This product fullls the medical product demands according to 2017/745/EU. According to the
classication criteria directives Annex IX, the product is classied as class I.
Embreis AB
Key to symbols
The following symbols are used on labels and/or in this manual.
Manufacturer
Date of manufacture
Serial number
Warning – see attached information
User information
This product is in Conformity with the Medical Device Regulation MDR
2017/745/EU

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Technical information
Amputation level: Transfemoral & transtibial
Sizes: 22-29 cm
User Weight Rating: 166 kg
Hardness Categories: 1-9
Attachment Type: Male pyramide
Heel Height: 10 mm
Foot Cover Skin Tones: Caucasian
Foot Cover CAP: Upon request
Carbon foot warranty: 36 months
Foot shell warranty: 6 months
E7W _ _ _
Impact
1-8
Size
22-29
Foot Module Part Number
E7F _ _ _
Size
22-29
Side
L-left
R-right
Foot Shell Part Number
Impact level Weight (kg)
Low Medium High
1 1 2 45 - 52
1 2 3 53 - 59
2 3 4 60 - 68
3 4 5 69 -77
4 5 6 78 - 88
5 6 7 89 - 100
6 7 8 101 - 116
7 8 117 - 130
Build height Size
(cm)
Height
(mm)
eWalk 22 - 25
26 - 29
63
65
Environmental Conditions
Mechanical vibrations or impacts X
Dust, sand, excessive water retention particles X
Sweat, urine, fresh water, salt water, acids X

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Construction and Function
The eWalk prosthetic foot was developed for the needs of users with activity level K2. The
foot is suitable for walking on various surfaces.
! The product is intended exclusively for lower limb ttings.
! Patient weights that the product can be used are given under technical information,
page 3.
General safety instructions
! Do not expose the product to unallowable environmental conditions given under tech-
nical information, page 3. (Inform the patient)
! If there is any visible damage, stop using the product. (Inform the patient)
! Do not hesitate by considering the repair and maintenance periods specied for the
product. (inform the patient)
! Only use the product on a single patient.
! If there is mechanical damage to the product, check its function, or contact the autho-
rized institution. (Inform the patient)
Before installing the Prosthesis
• Plantarex / Dorsiex foot to t shoe heel height.
• Adduct / Abduct socket to provide proper front plane angle.
• Flex or extend the socket to ensure proper sagittal plane angle.
• Move the socket linearly to ensure that the weight line falls along the leading edge of the
pylon.
Installation
! The applicability of the products has been tested only with products in the ORTOTEK
modular system.
! Use the product with parts that can be applied together.
The eWalk carbon foot module consists of an assembled carbon ber composite component,
baseplate, Spectra ™ socks and foot shell. Rubber reinforcing pads are provided to increase
the heel stiness level. After dynamic alignment, secure the appropriate torque pyramid set
screws with a threaded locking adhesive.

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Dynamic Alignment
! During the loading response, the heel arm stores energy and releases it in the middle.
! This movement helps the spine to store energy and provides momentum to release it
during the terminal stop.
! To optimize rollover movement from heel to foot, set the following variables:
- Front / rear foot placement
- Dorsiexion / plantarexion
- Heel stiness
! Check the prostheses after 30 days of use. (Inform the patient)
! Periodic controls deemed appropriate for the implementer should be made. (Inform the
patient)
The eWalk carbon foot module consists of an assembled carbon ber composite component,
baseplate, Spectra ™ socks and foot shell. Rubber reinforcing pads are provided to increase
the heel stiness level. After dynamic alignment, secure the appropriate torque pyramid set
screws with a threaded locking adhesive.
Troubleshooting
If the heel is very soft
Indications:
• The foot straight takes place very quickly.
• The toe feels extremely sti.
Solutions:
• The socket is moved forward with respect to the foot
• Rubber reinforcement bumpers are installed.
If the heel is very hard
Indications:
• Fast knee exion, instability.
• Advance from heel to toe.
• Feeling the lack of energy return.
Solutions:
• Slide the socket to the rear according to the foot.
• Verify the appropriate sub-module category.

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If the foot module is too hard or soft
Indications:
• Flat point in rollover movement in slow cadences.
Solutions:
• A lower category will suit you to the foot module.
If the foot module is too soft
Indications:
• Noise at initial contact.
• Extreme foot deection with high eective activity.
Solutions:
• A higher or lower category will suit you to the foot module.
Spectra™ Sock
A Spectra ™ sock is used to protect the crust and minimize noise. Spectra ™ socks should be
changed at intervals appropriate to the user’s level of activity. Failure to inspect and replace
Spectra ™ socks may insert the foot pod prematurely and void the warranty.
Warranty Terms and Conditions
The product is warranted from the date of purchase and the warranty period is 3 years from
the date of purchase.
• In order for the warranty conditions to be valid, the practitioner Prosthetics-Orthotics
specialist must be certied.
• Embreis AB does not assume any responsibility for damages caused by improper transi-
tion parts.
• Embreis AB is not responsible for the problems caused by the errors of the applicators
and users.
• In the event of a successful warranty claim, Embreis AB will replace the product with a
eWalk model of equal value.
• To make a warranty claim for eWalk, please contact Embreis Customer Support stating
the batch number and then return the defective product together with the completed
returns form. Returns forms are available at www.embreis.com or from Embreis Custom-
er Support.

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Embreis AB
Tumstocksvägen 11B
S-187 66 Täby
Sweden
Tel. + 46 8 410 621 00
[e-mail]
www.embreis.com

Embreis AB Tumstocksvägen 11B S-187 66 Täby Sweden
Tfn + 46 8 410 621 00 [e-mail] www.embreis.com