Otto Bock 12K100N 50-S Instructions For Use Manual page 19

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  • ENGLISH, page 11
10 Assemble the DynamicArm
After adaptation of the 12K100N=50-S DynamicArm , you can fit the prosthesis with the prosthetic socket.
1. Dismantle the lamination ring of the 12K100N=50-S as well as the prosthetic socket of the 12K100N
DynamicArm (see section 6, items 4 – 7).
2. S crew the socket onto the elbow joint. Or turn the friction screw until the socket can be screwed on the
elbow joint (see 647G152 Instructions for Use).
3. Remove the Allen head screw. Then replace the red assembly clamp with the band clamp and reinstall the
Allen head screws (see 647G152 Instructions for Use).
4. Turn the friction screw to set the friction of humeral rotation (see 647G152 Instructions for Use).
5. Adjust compensation to the patient by turning the finger wheel (see 647G152 Instructions for Use).
11 Technical Data
Power supply
Charging temperature:
Weight (dependent on forearm length)
Maximum lifting force:
Maximum load
Flexion angle
Operating temperature range
Storage and transport temperature in original packaging
Relative humidity
Storage and transport temperature without original packaging: -25 – 70 °C
11.1 Disposal
This product may not be disposed of with regular domestic waste. Disposal that is not in accordance
with the regulations of your country may have a detrimental impact on health and the environment.
Please observe the information provided by the responsible authorities in your country regarding return
and collection processes.
12 Liability
Otto Bock Healthcare Products GmbH, hereinafter called manufacturer, assumes liability only if the user observes
the product's specified fabrication and use instructions, adheres to its care instructions, and follows its service
schedule. This product may only be used in combination with components that have been authorized by the manu-
facturer (please refer to the instructions for use and catalogs). The manufacturer assumes no liability for damage
caused by component combinations (use of third-party products) and applications which it did not authorise.
This product may only be opened and repaired by authorized Ottobock staff.
13 Trademarks
All product names mentioned in this accompanying document are subject without restriction to the respective ap-
plicable trademark laws and the property of the respective owners. All brands, trade names or company names
may be registered trademarks and are the property of the respective owners.
Should trademarks used in this accompanying document fail to be explicitly identified as such, this does not justify
the conclusion that the denotation in question is free of third-party rights.
14 CE conformity
This product meets the requirements of the 93/42/EWG guidelines for medical products. This product has been
classified as a class I product according to the classification criteria outlined in appendix IX of the guidelines.
The declaration of conformity was therefore created by Ottobock with sole responsibility according to appendix
VII of the guidelines.
This product also meets the requirements of the 1999/5/EC Directive for radio equipment and telecommunica-
tions terminal equipment. The declaration of conformity was created by Ottobock according to appendix III of
the guidelines. A copy of the declaration of conformity can be requested from the manufacturer (see last page).
DynamicArm Service (Service/Test)
Li-Ion battery
> 0 °C
approx. 1000 g
50 N
approx. 60 N
approx. 15° to 145°
5 – 40 °C
-25 – 70 °C
1 5% to 93% relative humidity, non-condensing
Ottobock | 19

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