Environmental Conditions - Ossur RE-FLEX ROTATE Gebrauchsanweisung

Debris between blades
• Noise may occur if sand or debris are present between the blades.
• The prosthetist should remove the footcover and Spectra sock from
the device, and use compressed air to remove sand or debris.
Note: The device should always be used with a foot cover and Spectra
sock to minimize dust and dirt from entering between carbon blades.

ENVIRONMENTAL CONDITIONS

• Environmental operating temperature: -15°C to 50 °C (-5°F to 122°F).
• Operating humidity: 10% - 95% Relative Humidity.
• Shipping and storage temperature: -20°C to 70°C (-4°F to 158°F).
• Shipping humidity: < 95% no condensation, standard shipping
requirements apply.
LIABILITY
The manufacturer, Össur, 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
COMPLIANCE
This device has been tested according to ISO 10328 standard to two
million load cycles. Depending on the user's activity this corresponds to
a duration of use of two to three years. We recommend carrying out
ISO - "P" - "m"kg *)
*) Body mass limit not to be exceeded!
For speci c conditions and limitations of use see
manufacturer's written instructions on intended use!
Re-Flex Rotate
Category
1
2
3
4
5
6
7
8
ISO 10328 - label
Weight (Kg)
52
59
68
77
88
100
116
130
yearly safety checks. This device
has been tested for moderate
impact level use. Please refer to
the category selection chart for
low and high impact level use. In
the ISO 10328 standard, test
levels (P) are assigned to certain
maximal body masses (m).
Weight (lbs)
115
130
150
170
194
220
256
287
Label text
ISO 10328–P3–52–kg
ISO 10328–P3–59–kg
ISO 10328–P3–68–kg
ISO 10328–P4–77–kg
ISO 10328–P4–88–kg
ISO 10328–P5–100–kg
ISO 10328–P6–116–kg
ISO 10328–P6–130–kg
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