Ce-Konformität; Explanation Of Symbols; Scope Of Delivery; Instructions For Use - Otto HarmonyP3 4R147 Instrucciones De Uso

6.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie 93/42/EWG für Medizinpro-
dukte. Aufgrund der Klassifizierungskriterien nach Anhang IX dieser Richtlinie wurde das Produkt
in die Klasse I eingestuft. Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.
INFORMATION
Last update: 2015-07-01
• Please read this document carefully before using the product.
• Follow the safety instructions to avoid injuries and damage to the product.
• Instruct the user in the proper and safe use of the product.
• Please keep this document in a safe place.

Explanation of symbols

Warnings regarding possible risks of accident or injury.
CAUTION
Warnings regarding possible technical damage.
NOTICE
Additional information on the fitting / use.
INFORMATION
INFORMATION
Please read these instructions for use carefully and pay special attention to the safety
instructions!

1 Scope of delivery

The Harmony P3 is delivered with the following components:
1. 4R147 Harmony P3 Pump (incl. 4X147 Functional Ring*)
2. 2R117 Socket Connector (2x)
3. 4Y360 Muffler
4. 4Y383 Exhaust Flange Kit
5. 647H14

Instructions for Use

* Additional versions of the 4X147 Functional Ring can be ordered separately (for selections refer
to Section 4.5.1).
2 Description

2.1 Indications for use

The Harmony P3 Pump is a component of the Harmony Elevated Vacuum System, which also in-
cludes a Total Surface Weight Bearing Socket, Polyurethane Liner, Air Wick, and Sealing Sleeve.
The Harmony System is to be used solely for the prosthetic fitting of the lower limbs.
­armonyy3 44147
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