Legal Information; Technical Data - Ottobock Harmony E2 4R152 Serie Instrucciones De Uso

Required materials:
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Vessel with 30 ml to 60 ml distilled water, one collecting vessel
Preparations required:
Vacuum pump installed on adapter plate and in standby mode, prosthesis taken off the leg
1) Dip the outlet hose into the vessel with distilled water.
2) Hold the socket in such a way that the water runs into the collecting vessel during flushing.
3) Set the selector switch to reverse mode.
4) Allow the vacuum pump to run until the water has been pumped through the entire system.
5) Allow the pump to dry run for 15 s in order to pump out any remaining water.
6) Set the selector switch to standby mode.
7) Clean the interior surface of the socket.
7 Maintenance
► A visual inspection and functional test of the prosthetic components should be performed
after the first 30 days of use.
► Inspect the entire prosthesis for wear during normal consultations.
► Conduct annual safety inspections.
8 Disposal
In some jurisdictions it is not permissible to dispose of these products with unsorted
household 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
instructions of your national authority pertaining to return and collection.

9 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
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 disregarding the information in 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.
The product meets the requirements under the RoHS Directive 2011/65/EU of the European Par­
liament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous sub­
stances in electrical and electronic equipment.

10 Technical data

Reference number
Weight [g]
System height [mm]
Material
Max. body weight [kg]
24
4R152* Harmony
E2
185
95
–
–
4R153 adapter 4R153=1 adapter
plate plate with offset
125
22
Aluminium
150
160
22
Aluminium
150