Intended Use; Indications For Use; Area Of Application; Conditions Of Use - Otto Bock 1B1-2 Meridium Instructions For Use Manual

The product features MyModes for special motion types (e.g. cross-country skiing, ...). These are
pre-configured by the prosthetist using the adjustment software and can be activated with special
motion patterns, the cockpit app and the remote control (optional accessory) (see Page 66).
If configured by the prosthetist, an additional mode "Ankle lock" can also be selected, locking the
ankle joint of the prosthetic foot in its current position.
In case of a system malfunction, safety mode makes restricted operation possible. Predefined
resistance parameters are configured in the product for this purpose (see Page 72).
Empty battery mode permits safe walking when the battery is drained. Resistance parameters that
are predefined by the product are configured for this purpose (see Page 72).
The microprocessor-controlled hydraulic unit offers the following advantages
• Approximation of the physiological gait pattern
• Stable standing on even and inclined surfaces
• Adaptation of product characteristics to various surfaces, inclines, gait situations, walking
speeds and heel heights

3 Intended use

3.1 Indications for use

The product is to be used solely for lower limb exoprosthetic fittings.

3.2 Area of application

Our components perform optimally when paired with appropriate components based upon weight
and mobility grades identifiable by our MOBIS classification information and which have appro­
priate modular connectors.
The product is recommended for mobility grade 2 (restricted outdoor walker),
mobility grade 3 (unrestricted outdoor walker) and mobility grade 4 (unrestricted
m°
outdoor walker with particularly high demands).
kg
Foot size [cm]
Max. body weight [kg]

3.3 Conditions of use

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, run­
ning, ...) or extreme sports (free climbing, paragliding, etc.).
Permissible ambient conditions are described in the technical data (see Page 80).
The product is intended exclusively for use on one patient. Use of the product by another person
is not approved by the manufacturer.

3.4 Service Life

The product is a wear part, which means it is subject to natural wear and tear. The service life
diminishes or increases depending on the individual level of use. Only when the instructions for
use are observed it is possible to achieve the maximal service life, in dependence of the level of
use.
This product has been tested by the manufacturer with 2 million load cycles according to ISO
22675. Depending on the patient's activity level, this corresponds to a service life of 2 to 3 years.

3.5 Indications

• For users with unilateral knee disarticulation and unilateral transfemoral amputation
• Users with unilateral or bilateral transtibial amputation
24 to 25
100
26 to 29
125
47