Construction And Function; Combination Possibilities; Intended Use; Environmental Conditions - Ottobock 4R182 Harmony P4 modular Instrucciones De Uso

1.1 Construction and Function

The 4R182 Harmony P4 modular and 4R183 Harmony P4 HD modular mechanical vacuum
pumps generate a vacuum in the prosthetic socket that improves the connection with the residual
limb. The vacuum pumps have a four-hole connector for mounting, for example with a socket
adapter.
While walking, the vacuum pump is alternately compressed and released again. This generates
the vacuum and simultaneously dampens vertical impact loads. The design also permits slight tor­
sion of the prosthetic socket relative to the foot.

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.
Limited combination options for Ottobock components

2 Intended use

2.1 Indications for use
The product is intended exclusively for lower limb exoprosthetic fittings.
2.2 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
• The maximum approved body weight is specified in the technical data (see Page 18).
The product must be used in TT prostheses only.

2.3 Environmental conditions

Storage and transport
Temperature range –20 °C to +60 °C (–4 °F to +140 °F), relative humidity 20 % to 90 %, no mechanical
vibrations or impacts
Allowable environmental conditions
Temperature range: –10 °C to +45 °C
Moisture: relative humidity: 20% to 90%, non-condensing
Chemicals/liquids: fresh water as dripping water, occasional contact with salty air (e.g. near the ocean)
Solids: dust
Prohibited environmental conditions
Chemicals/moisture: salt water, perspiration, urine, acids, soapsuds, chlorine water
Solids: dust in high concentrations (e.g. construction site), sand, highly hygroscopic particles (e.g. talcum)

2.4 Service life

This prosthetic component has been tested by the manufacturer for 3 million load cycles accord­
ing to ISO 10328. Depending on the patient's activity level, this corresponds to a service life of 3
to 5 years.
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