Rehab'Impulse SACH 2.0 User manual

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Prosthetic Foot SACH 2.0
Instructions for Use
Please read this document carefully and follow the safety instructions.
Item codes: see bottom of document
Functions and benefits
The Rehab'Impulse Prosthetic Foot SACH 2.0 (Solid-Ankle Cushion-Heel) is made of soft thermoplastic
polyurethane foam moulded over a polyoxymethylene core. It is designed to provide the user with a
cushioned heel and a slightly flexible keel that offers a smooth rolling action during stance phase. The
cosmetic toe allows wearing of sandals and gives the foot a natural appearance.
Intended use
This product is intended for prosthetic fitting on adults and children with activity levels K1 (household
ambulator) and K2 (limited community ambulator).
Sizes 14 to 17 (child): Approved for a body weight up to 45kg (P2)
Sizes 18 to 21 (child): Approved for a body weight up to 60kg (P3)
Sizes 22 to 27 (adult): Approved for a body weight up to 80kg (P4)
Size 28 (adult): Approved for a body weight up to 100kg (P5)
Residual risks, contraindications
n/a

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Device specifications
1. Foot Shell (TPU foam)
2. Keel
3. Screw and Washer
Training
Please follow the ICRC manufacturing guidelines for transtibial or trans-femoral prosthesis:
https://www.icrc.org/en/doc/assets/files/other/eng-transtibial.pdf
https://www.icrc.org/en/doc/assets/files/other/eng-transfemoral.pdf
Storage/handling
•Store product in dry conditions
•Store at room temperature (ideally between 15°C and 25°C)
•Keep out of direct sunlight or other sources of light with a high UV content
•Take precautionary measures against sparking and fire
Environmental conditions
Recommended environmental conditions:
•Temperature range for use : -10°C to 60°C (14°F to 140°F)
•Relative humidity 0% to 90%, no condensing situation
•Avoid exposure to dust, sand, salt water, acids and urine
Included in delivery
•1x Foot SACH 2.0
•Adult: 1x Socket head cap screw, stainless steel, M10x80mm
•Child: 1x Socket head cap screw, stainless steel, M8x80mm
•Adult: 1x Ribbed lock washer M10
•Child: 1x Ribbed lock washer M8
Bench alignment
The ankle alignment system allows dorsal and plantar flexion and rotational alignment so that the prosthesis
can be adjusted to the user's anatomy.
All alignment should be done with the user's shoe fitted on the prosthetic foot. Alternatively, use a spacer
under the heel of the prosthetic foot representing the effective heel height of the shoe.
1
3
2

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The alignment can be adjusted for heel heights between 0mm and 20mm on adult sizes, but a heel height of
10 mm is recommended.
•It is recommended to position the alignment reference line from the socket at 1/3 of the foot length
starting from the heel
•An external rotation of 5 to 7° is recommended
Static Alignment
Static alignment should be verified with the user standing in upright position, with both shoes flat on the
floor and with his weight equally distributed on both legs. For more security, alignment verification is
recommended to be done with the user standing between parallel bars.
Dynamic alignment
Observe the user's gait between parallel bars. Check for a smooth transition from heel strike to toe-off.
When standing upright, make sure the user’s heel and toes are both touching the floor and that they are
evenly loaded.
In the case of transtibial amputees, make sure that the physiological knee flexion is achieved in stance
phase.
Maintenance
This device is designed for low maintenance. The prosthetic component should be inspected after the first
30 days of use. After this period it is recommended to inspect the device at least every six months for signs
of unusual wear. If the device is used in a corrosive environment or subjected to excessive moisture, this
period shall be shortened.
1/3
2/3
Alignment Reference Line
(from socket or knee)

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Cleaning and care
This device can be cleaned using mild soap or solvent followed by rinsing with water. Allow device to dry
completely before use. Avoid strong acid (pH=4 or less) and oxidizing agents.
This device has been engineered for a service life of 2-3 years depending on user's activity level. Scheduling
of regular maintenance lies within the discretion of the service provider. The user shall discontinue use and
report to the service provider in the event of any breakage, failure, change in function, or any unusual wear.
Disposal
Users are advised to return defective or worn out products to their clinician.
Please note that disposal of this product with regular domestic waste may not be permitted in all countries
of use. Not following the disposal regulations of the responsible authorities may have a detrimental impact
on health and environment.
Reusability
This device is intended for single-use only.
Compatibilities
The prosthetic foot SACH 2.0 is compatible with the Rehab'Impulse modular system.
Sizes 14-21:
•74-00223 Module System, Transfemoral, Child
•74-00221 Module System, Transtibial, Child
•74-00404 Module System, Long Stump, Child
Sizes 22-28:
•74-00134 Module System, Transfemoral, Adult
•74-00137 Module System, Transtibial, Adult
•74-00229 Module System, Long Stump, Adult
•74-00227 Module System, M10 Connector, Child
Spare parts
Please contact manufacturer.
Warnings, precautions
Using the product without following these instructions for use may cause injury or harm to the user and/or
damage the product. This device shall be fitted by trained prosthetists only. Ensure that the approved
service life of 2 million cycles is not exceeded. Do not expose the product to environmental conditions other
than the one specified in this instruction. If damage is apparent or in case of doubt, do not continue using
the product. Take suitable measures as required (e.g. cleaning, repair, replacement by trained P&O
personal). In case of contact with salt water, acid, abrasive substances or any substance identified above,
promptly clean the product in accordance with the chapter ”Cleaning and Care”.
Compliance
This device has been tested according to the ISO 10328 standard to 2 million load cycles.
Sizes 14 to 17 (child): Approved for a body weight up to 45kg (P2)
Sizes 18 to 21 (child): Approved for a body weight up to 60kg (P3)
Sizes 22 to 27 (adult): Approved for a body weight up to 80kg (P4)
Size 28 (adult): Approved for a body weight up to 100kg (P5)

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Depending on the user’s activity level, this corresponds to a service life of two to four years. It is
recommended to carry out regular safety checks.
CE Conformity
This product meets the requirements of the EU MDR 2017-745 guidelines for medical products. It has been
classified as a Class I product according to the classification criteria outlined in Appendix VIII of the
guidelines.
Item codes
REF
Description English
REF
Description English
74-00157
Foot, SACH 2.0, Size 14, Left, Olive
74-00215
Foot, SACH 2.0, Size 21, Right, Olive
74-00161
Foot, SACH 2.0, Size 14, Left, Terra
74-00219
Foot, SACH 2.0, Size 21, Right, Terra
74-00159
Foot, SACH 2.0, Size 14, Right, Olive
74-00139
Foot, SACH 2.0, Size 22, Left, Olive
74-00163
Foot, SACH 2.0, Size 14, Right, Terra
74-00143
Foot, SACH 2.0, Size 22, Left, Terra
74-00165
Foot, SACH 2.0, Size 15, Left, Olive
74-00141
Foot, SACH 2.0, Size 22, Right, Olive
74-00169
Foot, SACH 2.0, Size 15, Left, Terra
74-00145
Foot, SACH 2.0, Size 22, Right, Terra
74-00167
Foot, SACH 2.0, Size 15, Right, Olive
74-00147
Foot, SACH 2.0, Size 23, Left, Olive
74-00171
Foot, SACH 2.0, Size 15, Right, Terra
74-00151
Foot, SACH 2.0, Size 23, Left, Terra
74-00173
Foot, SACH 2.0, Size 16, Left, Olive
74-00149
Foot, SACH 2.0, Size 23, Right, Olive
74-00177
Foot, SACH 2.0, Size 16, Left, Terra
74-00153
Foot, SACH 2.0, Size 23, Right, Terra
74-00175
Foot, SACH 2.0, Size 16, Right, Olive
74-00087
Foot, SACH 2.0, Size 24, Left, Olive
74-00179
Foot, SACH 2.0, Size 16, Right, Terra
74-00091
Foot, SACH 2.0, Size 24, Left, Terra
74-00181
Foot, SACH 2.0, Size 17, Left, Olive
74-00089
Foot, SACH 2.0, Size 24, Right, Olive
74-00185
Foot, SACH 2.0, Size 17, Left, Terra
74-00093
Foot, SACH 2.0, Size 24, Right, Terra
74-00183
Foot, SACH 2.0, Size 17, Right, Olive
74-00095
Foot, SACH 2.0, Size 25, Left, Olive
74-00187
Foot, SACH 2.0, Size 17, Right, Terra
74-00099
Foot, SACH 2.0, Size 25, Left, Terra
74-00189
Foot, SACH 2.0, Size 18, Left, Olive
74-00097
Foot, SACH 2.0, Size 25, Right, Olive
74-00193
Foot, SACH 2.0, Size 18, Left, Terra
74-00101
Foot, SACH 2.0, Size 25, Right, Terra
74-00191
Foot, SACH 2.0, Size 18, Right, Olive
74-00103
Foot, SACH 2.0, Size 26, Left, Olive
74-00195
Foot, SACH 2.0, Size 18, Right, Terra
74-00108
Foot, SACH 2.0, Size 26, Left, Terra
74-00197
Foot, SACH 2.0, Size 19, Left, Olive
74-00106
Foot, SACH 2.0, Size 26, Right, Olive
74-00201
Foot, SACH 2.0, Size 19, Left, Terra
74-00110
Foot, SACH 2.0, Size 26, Right, Terra
74-00199
Foot, SACH 2.0, Size 19, Right, Olive
74-00112
Foot, SACH 2.0, Size 27, Left, Olive
74-00203
Foot, SACH 2.0, Size 19, Right, Terra
74-00116
Foot, SACH 2.0, Size 27, Left, Terra
74-00205
Foot, SACH 2.0, Size 20, Left, Olive
74-00114
Foot, SACH 2.0, Size 27, Right, Olive
74-00209
Foot, SACH 2.0, Size 20, Left, Terra
74-00118
Foot, SACH 2.0, Size 27, Right, Terra
74-00207
Foot, SACH 2.0, Size 20, Right, Olive
74-00120
Foot, SACH 2.0, Size 28, Left, Olive
74-00211
Foot, SACH 2.0, Size 20, Right, Terra
74-00124
Foot, SACH 2.0, Size 28, Left, Terra
74-00213
Foot, SACH 2.0, Size 21, Left, Olive
74-00122
Foot, SACH 2.0, Size 28, Right, Olive
74-00217
Foot, SACH 2.0, Size 21, Left, Terra
74-00126
Foot, SACH 2.0, Size 28, Right, Terra
IFU ID and date
IFU-Foot-SACH2.0-EN-V3.0 – 10.03.2021
alfaset
Rue des Terreaux 48
CH-2300 La-Chaux-de-Fonds
Switzerland
[phone]
www.alfaset.ch
[email protected]