Use Environment - Ossur D/P FLEXION Gebrauchsanweisung

RETROFITTING OF D/P FLEXION TO K2 SENSATION OR FLEX-FOOT
BALANCE
In cases where D/P Flexion is being retrofitted to K2 Sensation or Flex-
Foot Balance, or any other case where the D/P Flexion module needs to
be attached to the foot the following torque specifications apply: 15Nm.
Loctite 243 also needs to be applied to threads (Figure 9).
CAUTION
Avoid placing hands or fingers near moving parts.
Please be aware that D/P Flexion is nickel coated and is filled
with hydraulic fluid. Both of which can cause allergic reaction
if it comes in contact with bare skin.

USE ENVIRONMENT

• Environmental operating temperature: -15 °C (+5 °F) to 50 °C (122 °F).
• Operating humidity: 10%-95% Relative humidity.
• Shipping and storage temperature: -20 °C- (-4 °F) to 70 °C (158 °F).
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.
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. In the standard mentioned, test
ISO
*) Body mass limit not to be exceeded!
For speci c conditions and limitations of use see
manufacturer's written instructions on intended use!
adequately on the basis of the specified load level.
Category
0
1
2
3
4
5
- "P" - "m"kg *)
ISO 10328 - label
Weight (Kg)
44
61
80
97
114
136
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 have been adapted
Label text
ISO 10328–P3–44–kg
ISO 10328–P3–61–kg
ISO 10328–P4–80–kg
ISO 10328–P5–97–kg
ISO 10328–P5–114–kg
ISO 10328–P6–136–kg
6