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Idiomas disponibles
Idiomas disponibles
2
0
2
1
Pass on § 3, 7, 8, and 9 of these instructions to the Patient.
1 INCLUDED ITEMS
Part Description
ShockWave Foot
Spectra™ Sock
Heel Bumper Kit (Sizes 23-25 cm)
Heel Bumper Kit (Sizes 26-28 cm)
Heel Bumper Kit (Sizes 29-30 cm)
2 DESCRIPTION AND PROPERTIES
A. Description
The ShockWave is an energy storing prosthetic foot with J-shaped keel, heel component, and a vertical loading pylon that
provides controlled motion for shock absorption and axial rotation.
B. Properties
Build Height
Weight based on a size 26cm, Cat 4 Foot Module with Foot Shell and Spectra Sock.
Build height based on 23cm, 26cm or 29cm, Cat 4 Foot Module with Foot Shell, Spectra
This device has undergone a two-million-cycle test, in accordance with standard ISO 10328 (at a P7 load level for 147kg [325
lbs.]), which corresponds to a service life of 2 to 3 years, depending on the patient's activity level.
Category Selection Guide
lb
Weight
kg
Low
Activity
Moderate
Level
High
3 INTENDED USE/INDICATIONS
This medical device is supplied to healthcare professionals (prosthetists) who will train the patient in its use. The prescription is
made by a doctor together with the prosthetist, who assess the patient's ability to use it.
This device is for SINGLE PATIENT use. It should not be reused on another patient.
4 CLINICAL BENEFITS
The device provides clinical benefits and performance including:
•
Ability to ambulate on variable terrain
•
Shock absorption
•
Axial rotation
•
Reduced socket forces and increased comfort
Freedom ShockWave™ by PROTEOR
Prosthetist Instructions for use
Read before use
Foot Shell
Weight
23 – 25cm
26 – 28cm
29 – 30cm
Heel Rise
Sock, and 10mm heel rise.
110-115 116-130 131-150 151-170 171-195 196-220 221-255 256-285 286-325
44-52
53-59
1
1
1
2
2
3
This device is intended for use by prosthesis wearers who would benefit from the safety, stability,
and improved gait dynamics of the ShockWave. Users should meet the requirements of a
Medicare functional level of K3 or higher.
This device is indicated for use as a component in a prosthetic leg for individuals with unilateral
or bilateral lower-limb amputations or limb deficiencies, including:
•
Transtibial amputation
•
Transfemoral amputation
•
Knee disarticulation amputation
•
Hip disarticulation amputation
•
Congenital, lower-limb deficiencies
Maximum weight (load carrying included): See above table
Part Number
F20-S3-XXAYY-ZZ
FTC-3F-1XXX4-RX
FTC-2F-1XXX4-SX
SO-NPS-XXXXX-00
KIT-00-11463-00
KIT-00-11464-00
KIT-00-11465-00
2.20 lbs / 998g
6.9" / 175mm
7.3" / 186mm
7.8" / 198mm
3⁄8"/ 10mm
60-68
69-77
78-88
89-100 101-116 117-130 131-147
2
3
4
3
4
5
4
5
6
IFU-01-097
Rev C
2021-10
Included/Sold Separately
Included
Sold Separately
Included
Appropriate Kit Included
5
6
7
6
7
8
7
8
-
8
-
-
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