Intended Use; Indications For Use; Environmental Conditions; Service Life - Otto Bock Harmony E2 4R152 Instructions For Use Manual

1.2 Combination possibilities
This prosthetic component is compatible with Ottobock's system of modular connectors. Func­
tionality with components of other manufacturers that have compatible modular connectors has
not been tested.

2 Intended use

2.1 Indications for use

The product is intended exclusively for lower limb exoprosthetic fittings.
2.2 Area of application
• The maximum approved body weight is specified in the technical data (see Page 24).

2.3 Environmental conditions

Allowable environmental conditions
Temperature range for use: -10 °C to +60°C
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

Vacuum Pump
The Harmony E2 vacuum pump was tested by the manufacturer with 400 hours of pump opera­
tion. The vacuum pump starts up at irregular intervals that depend on the selected mode, patient
activity level and leak tightness of the overall system, including the prosthetic socket. Accordingly
the service life of the device is 3 to 5 years.
Adapter Plate
In general, all modular adapters are tested by the manufacturer for 3 million load cycles. Depend­
ing on the patient's level of activity, this corresponds to a service life of 3 to 5 years.
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible serious risks of accident or injury.
WARNING
Warning regarding possible risks of accident or injury.
CAUTION
Warning regarding possible technical damage.
NOTICE
3.2 General safety instructions
WARNING
Use of the vacuum pump in explosion-prone rooms
Explosion hazard due to sparks
Never use the vacuum pump in explosion-prone rooms.
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Remove the vacuum pump from the prosthesis prior to entering explosion-prone rooms. Do
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not take the vacuum pump along with you into the explosion-prone rooms.
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