Intended Use - Ottobock Harmony E2 4R152 Serie Instrucciones De Uso

1.1 Construction and Function
The 4R152 Harmony E2 electronic vacuum pump is a component of the Harmony system for the
generation of a high vacuum in the prosthetic socket. The vacuum pump and a prosthetic socket
fabricated using Harmony technology form a functional unit for transfemoral and transtibial pros­
theses. Adhesion between the prosthesis and the residual limb is improved by the high vacuum.
The vacuum pump is installed on the 4R153 adapter plate or the 4R153=1 adapter plate with off­
set. The adapter plate with offset can be used when a greater lateral clearance to the prosthetic
knee joint or prosthetic foot is required.
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 to be used solely for lower limb prosthetic 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
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