Application; Intended Use; Area Of Application; Environmental Conditions - Otto Bock 7E9 Instructions For Use Manual

2 Application

2.1 Intended Use

The prosthetic hip joint system is intended exclusively for the exoprosthetic fitting of patients with
hip amputations such as intertrochanteric amputation, hip disarticulation or hemipelvectomy.

2.2 Area of Application

The prosthetic hip joint can be used by active prosthesis wearers as well as prosthesis wearers
who require a high degree of safety. It offers dynamic comfort through hydraulic stance phase
and swing phase control.
Recommended for mobility grades 2 and 3 (restricted outdoor walker and unres­
tricted outdoor walker). Approved for a body weight of 125 kg max..
m°
kg
The prosthetic hip joint was designed for activities of daily life; it must not be used for sports.

2.3 Environmental Conditions

Allowable Environmental Conditions
Temperature range for use: -10 °C to +60 °C (14 °F to 140 °F)
Allowable relative humidity 0 % to 90 %, non-condensing
Unallowable environmental conditions
Mechanical vibrations or impacts
Perspiration, urine, fresh water, salt water, acids
Dust, sand, highly hygroscopic particles (e. g. talcum)

2.4 Service Life

This component was tested for 2 million load cycles in accordance with ISO 15032. Depending
on the user's level of activity, this corresponds to a service life of 2 to 3 years.

3 Safety

3.1 Explanation of warning symbols

Warnings regarding possible risks of accident or injury.
CAUTION
NOTICE Warnings regarding possible technical damage.

3.2 General Safety Instructions

CAUTION
Using the product without following the instructions for use
Deteriorating health condition and damage to the product because of failure to follow the safety
information
Observe the safety information in these instructions for use.
►
Make the patient aware of all safety instructions marked with "Inform the patient".
►
CAUTION
Excessive strain on the product
Fall due to breakage of load-bearing components
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