Legal Information; Trademarks; Technical Data - Ottobock Varos 5A60 Serie Instrucciones De Uso

Cleaning the Varos test set
CAUTION
Reuse on another patient and improper cleaning
Skin irritation, formation of eczema or infections due to contamination with germs.
► The product should only be used on the patient for whom it was fitted.
► If the product is to be used on another patient, it first has to be cleaned with a damp cloth
and mild detergent (e.g. 453H10=1 Ottobock DermaClean) and disinfected.
► If a surface disinfection process using an alcohol-based disinfectant without additional addit­
ives, for example "Terallin liquid", is used for disinfection, the application instructions and
safety notices of the disinfectant manufacturer have to be observed.
Required materials: colourless, alcohol-free disinfectant, soft cloth
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1) Disinfect the product with the disinfectant.
2) Dry the product with a cloth.
3) Allow to air dry in order to remove residual moisture.
10 Maintenance
► A visual inspection and functional test of the prosthetic components should be performed
after the first 30 days of use.
► Conduct annual safety inspections.

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 Trademarks

All product names mentioned in this document are subject without restriction to the respective
applicable trademark laws and are 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 document fail to be explicitly identified as such, this does not justi­
fy the conclusion that the denotation in question is free of third-party rights.
11.3 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.

12 Technical data

Ambient conditions
Transport in original packaging
Storage in original packaging
Storage and transport without packaging
48
-25 °C/-13 °F to +70 °C/+158 °F
-25 °C/-13 °F to +50 °C/+122 °F
Max. 90% relative humidity, non-condensing
-25 °C/-13 °F to +50 °C/+122 °F
Max. 90% relative humidity, non-condensing