Otto Bock 3R80 - Maintenance; Disposal; Legal Information; Liability

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7 Maintenance
CAUTION
Failure to follow the maintenance instructions
Risk of injuries due to changes in or loss of functionality and damage to the product
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Observe the following maintenance instructions.
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Arrange regular maintenance intervals with the patient depending on the level of use.
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Following an individual period for the patient to get accustomed to the prosthesis, check the
settings of the prosthetic joint and adapt them to the patient's requirements again as needed.
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The prosthetic components should be inspected after the first 30 days of use.
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Inspect the entire prosthesis for wear during normal consultations.
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Conduct annual safety inspections.
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As part of the safety inspections, inspect the prosthetic joint for wear and proper functionality.
Special attention should be paid to movement resistance, bearings and abnormal noises. Full
flexion and extension must be ensured at all times. Readjust as required.
8 Disposal
In some jurisdictions it is not permissible to dispose of the product with unsorted household
waste. Improper disposal can be harmful to health and the environment. Observe the information
provided by the responsible authorities in your country regarding return, collection and disposal
procedures.
9 Legal Information
9.1 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
device must only be operated with tested modular components in accordance with the MOBIS
Mobility System. The manufacturer is not liable for damage caused by component combinations
that were not authorised by the manufacturer.
9.2 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 guidelines. The declaration of conformity was therefore created by the manu
facturer with sole responsibility according to appendix VII of the guidelines.
10 Technical data
Reference Number 3R80 3R80=ST
Weight [g]
1240 1255
System height [mm]
163 179
Proximal system height up to the alignment reference
point [mm]
28 44
Distal system height up to the alignment reference point
[mm]
135
Knee flexion angle
150°
Proximal connection
Pyramid adapter Threaded connector
Distal connection
Tube clamp (Ø34mm)
Max. body weight [kg]
150
Mobility grade
3+4