Otto Bock Harmony P3 - Product Intended Use and Environmental Conditions; Indications for Use; Area of Application; Environmental Conditions

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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.
The Harmony system consists of a vacuum pump, a total surface weight-bearing socket, a poly
urethane liner and a sealing sleeve.
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
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.
m°
kg
The product is recommended for mobility grade2 (restricted outdoor walker),
mobility grade3 (unrestricted outdoor walker) and mobility grade4 (unrestricted
outdoor walker with particularly high demands).
• The maximum approved body weight is specified in the technical data (see page21).
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 (14°F to 113°F)
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 Lifetime
This product was tested by the manufacturer with 3million load cycles. Depending on the user’s
activity level, this corresponds to a maximum lifetime of 5years.
2.5 Qualification
• Fabricating the total surface weight-bearing socket: Fabricating a total surface weight-
bearing socket is required for the use of the product.
2.6 Absolute Contraindications
• Effectively non-weight-bearing residual limb end
• Neuromas in the area of the residual limb