Össur FLEX-SYMES Instrucciones Para El Uso página 9

FLEX-FOOT SOCK FCX63006/7
To protect the cover and avoid noise, a Flex-Foot sock is fitted over the
foot module before installing the cover. The sock should be loose in the
heel area.
SHOEHORN CM100068 (Figure 9)
When removing and installing the cover, use shoehorn to avoid damage
to foot or cover.
MAINTENANCE
The FLEX-SYMES can be used in water but warranty terms only apply if
the following conditions are met:
• The foot is cleaned with tap water after use in salt water and / or
freshwater.
• Immediately following contact with water, take the the foot cover off
the foot and dry thoroughly.
• The components used with the foot need to be waterproof as well.
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
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
Lable text
P3 ISO 10328 -
P3 ISO 10328 -
P4 ISO 10328 -
P4 ISO 10328 -
P4 ISO 10328 -
P3 52 kg
P3 59 kg
P4 68 kg
P4 77 kg
P5 88 kg
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