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Pass on § 12, 13, 14, 15, 17, 18 and 19 of these instructions to the patient.
1.
INCLUDED ITEMS
Sierra Foot with EVAQ8
EVAQ8 Rebuild Kit
EVAQ8 Release Valve
Black Spectra sock
Stiffening bumpers
Foot Shell Removal Tool
Foot shell with regular toe (no cap)
Foot shell with sandal toe (no cap)
2.
DESCRIPTION
Sierra® is an energy-return prosthetic foot consisting of:
•
A carbon keel
•
A carbon sole plate
•
A male pyramid connection
•
A Spectra sock
Available with regular toe or right or left sandal toe and delivered with a set of elastomer stiffening
bumpers (not with EVAQ8).
3.
PROPERTIES
Side
Size
Sandal toe option
Weight*
Build height*
Heel height
*Based on sizes 23, 26, 29, cat. 4, with foot shell, Spectra sock and 10 mm heel height
This device has been tested according to ISO 10328 for a maximum patient weight up to 166 kg for 2 million cycles.
Selection of foot category based on patient's weight and impact level
lbs
100-115 116-130 131-150 151-170 171-195 196-220 221-255 256-285 286-325 326-365
*)
Weight
kg
44-52
Low
Impact
Moderate
level
High
*)
Body mass limit not to be exceeded (ISO 10328)
4.
MECHANISM OF ACTION
During the strike phase, the sole and heel store energy, which they return in the middle of the stance phase. This property creates
the impetus enabling the forefoot to accumulate energy and return it upon the step completion.
5.
INTENDED USE/INDICATIONS
This medical device is supplied to healthcare professionals (prosthetists), who will train the patient in its use. The
prescription is drawn up by a doctor who assess the patient's ability to use the device.
This device is for multiple use on a SINGLE PATIENT. It must not be used on another patient.
Sierra® – FS1
Instructions for use for prosthetists
Read before use
Part description
Sierra Foot
504 g / 1.1 lbs
135 mm / 5.3''
53-59
60-68
1
1
2
1
2
3
2
3
4
Part number
FS1-00-0xAxx-xx*
FS1-V2-0xAxx-xx*
EV2RB
EVRV
S0-NPS-200xx-00*
KIT-00-1135U-00
ACC-00-10300-00
FTC-3M-1
FTC-2M-1
* See Catalog
Right or Left
22 to 25 cm
26 to 28 cm
Yes
Yes
597 g / 1.3 lbs
158 mm / 6.2''
10 mm /
69-77
78-88
89-100
3
4
5
4
5
6
5
6
7
Included / Sold separately
Included
Sold separately
Sold separately
Suitable sock included
Included (not with EVAQ8)
Sold separately
Sold separately
(See Catalog)
29 to 31 cm
No
756 g / 1.7 lbs
172 mm / 6.8''
3
⁄
"
8
101-116 117-130 131-147 148-166
6
7
7
8
8
9
IFU-01-013
Rev. B
2024-03
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9
9
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