Össur RE-FLEX SHOCK, Инструкция по эксплуатации

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CATEGORY SELECTION CHART
Please refer to the selection charts below to determine the appropriate
stiffness required according to Össur recommendations.
CLEANING
The product needs to be cleaned after contact with water, sand or dirt.
The filters need to be cleaned with air pressure.
(Figure 9)
MAINTENANCE
No component maintenance.
The filters need to be cleaned with air pressure
(Figure 9) .
Change spring : Remove the top and bottom pins using 4mm “hex-key”
and change the spring (Figure 4) . Apply Loctite 243 on threads and
tighten pins with 10Nm torque.
Change bushing in spring : Remove spring (see above) and press out the
bushings carefully. Press new bushings in and re-attach the spring (see
above).
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 10328 - “P” - “m”kg *)
*) Body mass limit not to be exceeded!
For specific conditions and limitations of use see
manufacturer’s written instructions on intended use!
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
have been adapted adequately on the
basis of the specified load level.
WEIGHT KG 45-52 53-59 60-68 69-77 78-88 89-100 101-116 117-130 131-147 148-166
WEIGHT LBS 99-115 116-130 131-150 151-170 171-194 195-220 221-256 257-287 288-324 326-366
Low Impact Level 1 1 2 3 4 5 6 7 8 9
Moderate Impact
Level
1 2 3 4 5 6 7 8 9 N/A
High Impact Level 2 3 4 5 6 7 8 9 N/A N/A