Otto Bock 1041 Dosi Symphysiolisis, Instructions For Use Manual

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6.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie
93/42/EWG für Medizinprodukte. Aufgrund der Klassifizierungskriterien
nach Anhang IX dieser Richtlinie wurde das Produkt in die Klasse I einge­
stuft. Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.
1 Foreword English
INFORMATION
Last update: 2018-04-20
► 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.
These instructions for use provide important information on the fitting and
application of the 1041 Dosi Symphysiolysis, 1045 Dosi Sacro and 7131 SI
Warm symphysis supports.
2 Intended use
2.1 Indications for use
The support is intended
exclusively
for orthotic fittings of the pelvis and
exclusively for contact with intact skin.
The support must be used according to the indication.
2.2 Indications
Indications must be determined by the physician.
•
Symphysis strain
• Sacroiliac loosening
2.3 Contraindications
2.3.1 Absolute Contraindications
Not known.
2.3.2 Relative Contraindications
The following indications require consultation with a physician: skin dis­
eases/injuries, inflammation, raised scars with swelling, reddening, and
warming in the area where the support is fitted, tumours, lymphatic conges­
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