Legal Information - Ottobock 3R67 Instrucciones De Uso

Cleaning with Disinfectants
Required materials: colourless, alcohol-free disinfectant (verify material compatibility!), soft
>
cloth
► Disinfect the product with the disinfectant.
► Dry the product with a cloth.
► Allow to air dry in order to remove residual moisture.
9 Maintenance
CAUTION
Failure to follow the maintenance instructions
Risk of injuries due to changes in or loss of functionality and damage to the product
► Observe the following maintenance instructions.
► NOTICE! Do not lubricate and grease the prosthetic joint.
► NOTICE! Repair work must be performed exclusively by the manufacturer's technical 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.
► Perform a safety inspection every 3 months.
► 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.
► In case of changes in prosthesis function or relevant patient changes (such as the activity
level, body weight, body height), perform unscheduled inspections and implement measures
according to the situation.
Inspecting and replacing the stop (
► Check the stop shown in Figure
thesis is inspected.
► Replace a damaged or missing stop in the illustrated sequence.
10 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.

11 Legal information

11.1 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 disregarding the information in this document, particularly due to improper
use or unauthorised modification of the product.
11.2 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.
26
10
on page 11 –
10
on page 11 for wear and integrity every time the pros­
)