Intended Use - Ottobock 4R88 Instrucciones De Uso

► Report each serious incident in connection with the product, in
particular a worsening of the state of health, to the manufacturer
and to the relevant authority in your country.
► Please keep this document for your records.
1.1 Construction and Function
Sliding tube clamp adapters permit translation adjustments at the
proximal end of a tube adapter. It therefore permits the distal compon­
ents of the modular prosthesis to be shifted in parallel, regardless of
the angle adjustment by the pyramid adapters. The adjustments can
be made either in the frontal plane (medial or lateral) or in the sagittal
plane (anterior or posterior).
This document applies to the following products: 4R88, 4R103
1.2 Combination possibilities
This prosthetic component is compatible with Ottobock's system of
modular connectors. Functionality with components of other manufac­
turers 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 fit­
tings.
2.2 Area of application
• The maximum approved body weight is specified in the technical
data (see Page 10).
4R88: Only use the product for TF prostheses directly below the
•
prosthetic knee joint.
Ottobock recommends the use of structural components with a dia­
meter of 34 mm when elevated loads are expected (e.g. for a transtibi­
al prosthesis).
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
Unacceptable environmental conditions
Chemicals/liquids: fresh water, salt water, perspiration, urine,
acids, soapsuds, chlorine water
Solids: dust, sand, highly hygroscopic particles (e. g. talcum)
2.4 Service life
In general, all modular adapters are tested by the manufacturer for
3 million load cycles. Depending on the user's activity level, this cor­
responds to a maximum service life of 5 years.
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible risks of accident or
CAUTION
injury.
Warning regarding possible technical damage.
NOTICE
3.2 General safety instructions
CAUTION
Excessive strain on the product
Risk of injury due to breakage of load-bearing components
► Use the product according to the specified area of application
(see Page 7).
7