Össur VARI-FLEX XC ROTATE XRPExyyz Mode D'emploi page 7

into the toe split. The thread of the sock should rest on top of foot
module and not underneath the toe split. The sock should be loose from
the heel area and secured proximally with the cable tie provided.
SHOE HORN (Figure 5 & 6)
When removing and installing the cover use shoehorn to avoid damage
to foot or cover.
LIABILITY
The manufacturer recommends using the device only under the specified
conditions and for the intended purposes. The device must be
maintained according to the instructions for use. The manufacturer is
not liable for damage caused by component combinations that were not
authorized by the manufacturer.
CE CONFORMITY
This device meets the requirements of the 93/42/EEC guidelines for
medical devices. This device has been classified as a class I device
according to the classification criteria outlined in appendix IX of the
guideline.
COMPLIANCE
This component has been tested according to ISO 10328 standard to two
million load cycles. Depending on the amputee's activity this
corresponds to a duration of use of two to three years. We recommend
carrying out regular yearly safety checks
ISO - "P" - "m"kg *)
*) Body mass limit not to be exceed!
For speci c conditions and limitations of use see
manufacturer's written instructions on intended use!
have been adapted adequately on the basis of the specified load level.
Category
1
2
3
4
5
6
7
8
• This manual is intended for use by a certified prosthetist.
In the standard mentioned, test levels
(P) are assigned to a certain maximal
body masses (m in kg). In some cases,
which are marked with, no test level is
assigned to the product related maximal
body mass. In these cases, the test loads
Category Össur high activity
Weight (Kg)
52
59
68
77
88
100
116
130
Lable text
P3 ISO 10328 -
P3 ISO 10328 -
P4 ISO 10328 -
P4 ISO 10328 -
P4 ISO 10328 -
P5 ISO 10328 -
P5 ISO 10328 -
P6 ISO 10328 -
P3 52 kg
P3 59 kg
P4 68 kg
P4 77 kg
P5 88 kg
P5 100 kg
P6 116 kg
P6 130 kg
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