Otto Bock Pheon 3R62 Instructions For Use Manual page 39

7 Maintenance
CAUTION
Failure to follow the maintenance instructions
Injuries due to changes in or loss of functionality and damage to the product
► Observe the maintenance instructions.
Inform the patient.
►
► NOTICE! Do not lubricate and grease the prosthetic joint.
► NOTICE! Repair work must be performed exclusively by manufacturer service.
► Arrange regular maintenance intervals with the patient depending on the level of use.
► 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.
► The prosthetic components should be inspected after the first 30 days of use.
► Inspect the entire prosthesis for wear during normal consultations.
► Conduct annual safety inspections.
► 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.
► Check the initial tension settings (EBS unit, extension assist) to make sure they are free of
play. Increase the initial tension if needed.
8 Disposal
This product may not be disposed of with regular domestic waste in all jurisdictions. Disposal that
is not in accordance with the regulations of the country where the product is used may have a det­
rimental impact on health and the environment. Please observe the information provided by the
responsible authorities in the country of use regarding return, collection and disposal procedures.
9 Legal Information
9.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descrip­
tions and instructions provided in this document. The manufacturer will not assume liability for
damage caused by disregard of this document, particularly due to improper use or unauthorised
modification of the product.
9.2 CE Conformity
This product meets the requirements of the European Directive 93 / 42 / EEC for medical devices.
This product has been classified as a class I device according to the classification criteria out­
lined in Annex IX of the directive. The declaration of conformity was therefore created by the man­
ufacturer with sole responsibility according to Annex VII of the directive.
10 Technical data
Reference number
Weight [g]
System height [mm]
Proximal system height up to the
alignment reference point [mm]
Distal system height up to the align­
ment reference point [mm]
3R62, 3R62=1
815
142
-3
3R62=KD,
3R62=1-KD
955
(incl. lamination anchor)
165
20
145
3R62=ST,
3R62=1-ST
850
160
15
Ottobock | 39