
1 Foreword
English
INFORMATION
Date of last update: 2021-05-27
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Please read this document carefully before using the product and observe the safety notices.
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Instruct the user in the safe use of the product.
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Please contact the manufacturer if you have questions about the product or in case of problems.
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Report each serious incident related to the product to the manufacturer and to the relevant authority in your
country. This is particularly important when there is a decline in the health state.
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Please keep this document for your records.
Note the instructions for use
This document contains the sections "Intended use" and "Safety", and does not replace the
instructions for use. The instructions for use are available in digital form (PDF format) (see page
2 of this document). To view PDF files, you need an Internet browser or other program capable
of opening this file format.
You may request a printed copy of the instructions for use under the link on page 2. This will be
delivered to the specified address within 7 days after the order is received.
The product "1B1-2=* Meridium" is referred to as the product/component/prosthesis/prosthetic foot below.
Basic UDI-DI: 40644110000000001B1-2G4
2 Intended use
2.1 Indications for use
The product is to be used
solely
for lower limb exoprosthetic fittings.
2.2 Conditions of use
m°
kg
The product is recommended for mobility grade 2 (restricted outdoor walker) and mobility
grade 3 (unrestricted outdoor walker).
The product was developed for everyday use and must not be used for unusual activities. These unusual activities
include, for example, sports with excessive impact load (tennis, basketball, running, ...) or extreme sports (free
climbing, paragliding, etc.).
Permissible ambient conditions are described in the technical data (Technical data).
The product is intended
exclusively
for use on
one
patient. Use of the product by another person is not approved
by the manufacturer.
Our components perform optimally when paired with appropriate components based upon weight and mobility
grades identifiable by our MOBIS classification information and which have appropriate modular connectors.
Foot size [cm]
24 to 25
26 to 29
Max. body weight [kg]
100
125
2.3 Indications
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For users with unilateral knee disarticulation and unilateral transfemoral amputation
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For users with unilateral or bilateral transtibial amputation
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The user must fulfil the physical and mental requirements for perceiving optical/acoustic signals and/or mech
anical vibrations
2.4 Contraindications
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All conditions which contradict or go beyond the specifications listed in the section on "Safety" and "Indica
tions for use".
12
Foreword
1B1-2=* Meridium
Содержание Meridium
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