Otto Bock 15K10 Instruction Manual page 5

9 Rechtliche Hinweise
Alle rechtlichen Bedingungen unterliegen dem jeweiligen Landesrecht
des Verwenderlandes und können dementsprechend variieren.
9.1 Haftung
Der Hersteller haftet, wenn das Produkt gemäß den Beschreibungen
und Anweisungen in diesem Dokument verwendet wird. Für Schäden,
die durch Nichtbeachtung dieses Dokuments, insbesondere durch
unsachgemäße Verwendung oder unerlaubte Veränderung des Pro­
dukts verursacht werden, haftet der Hersteller nicht.
9.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der Verordnung (EU) 2017/745
über Medizinprodukte. Die CE-Konformitätserklärung kann auf der
Website des Herstellers heruntergeladen werden.
1 Product description
INFORMATION
Date of last update: 2022-09-30
► Please read this document carefully before using the product
and observe the safety notices.
► Instruct the user in the safe use of the product.
► Please contact the manufacturer if you have questions about the
product or in case of problems.
► Report each serious incident related to the product to the manu­
facturer and to the relevant authority in your country. This is par­
ticularly important when there is a decline in the health state.
► Please keep this document for your records.
1.1 Construction and Function
The 15K10 modular foam kit serves to create an attractive exterior
contour for modular prostheses from the forearm to the shoulder
girdle level. It contains the 13R8=64 mounting flange.
1.2 Combination possibilities
This prosthetic component is compatible with Ottobock's system of
modular connectors. Functionality with components of other manufac­
turers that have compatible modular connectors has not been tested.
2 Intended use
2.1 Indications for use
The product is to be used solely for upper limb prosthetic fittings.
2.2 Area of application
The product serves to create passive arm prostheses.
2.3 Environmental conditions
Allowable environmental conditions
Temperature range for use: -10 °C to +45 °C
Relative humidity: max. 90%, non-condensing
English
Moisture: fresh water and salt water as splashing water, sweat
Unallowable environmental conditions
Mechanical vibrations or impacts
Acids
Dust, sand, highly hygroscopic particles (e.g. talcum), smoke
3 General safety instructions
CAUTION!
Risk of injury and risk of product damage
► Keep the product away from open flames, embers and other
sources of heat.
► The product may only be used by one person; reuse on another
person is prohibited.
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