Foreword; Product Description; Design; Function - Otto Bock Genium 3B1-3 Instructions For Use Manual

Foreword

1 Foreword
INFORMATION
Date of last update: 2020-05-28
► 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 in connection with the product, in particular a worsening of the state of health, to
the manufacturer and to the relevant authority in your country.
► Please keep this document for your records.
The product "3B1-3, 3B1-3=ST Genium" is called the product/prosthesis/knee joint/component in the following.
These instructions for use provide you with important information on the use, adaptation and handling of the
product.
Only put the product into use in accordance with the information contained in the accompanying documents sup­
plied.
According to the manufacturer (Otto Bock Healthcare Products GmbH), the patient is the operator of the product
according to the IEC 60601-1:2005/A1:2012 standard.

2 Product description

2.1 Design

The product consists of the following components:

2.2 Function

This product features microprocessor control of the stance and swing phase.
The microprocessor uses the measurements of an integrated sensor system as a basis to control a hydraulic unit
that influences the damping behaviour of the product.
These sensor data are updated and evaluated 100 times per second. As a result, the behaviour of the product is
adapted to the current motion situation (gait phase) dynamically and in real time.
The product can be individually adapted to the needs of the patient with the X-soft adjustment software.
The product features MyModes for special motion types (e.g. cycling ...). These are pre-configured using the
adjustment software and can be activated with special movement patterns and the Cockpit app (see Page 43).
In case of a product malfunction, safety mode makes restricted operation possible. Resistance parameters that are
predefined by the product are configured for this purpose (see Page 46).
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 45).
12
1
2
3
4
5
8
7
8
1. Proximal pyramid adapter
2. Optional flexion stops
3. Battery
4. Hydraulic unit
5. LED (blue) as indicator for the Bluetooth connec­
tion
6. Receiver of the inductive charging unit
7. Distal tube clamp screws
8. Connecting cable for tube adapter
Genium 3B1-3/3B1-3=ST