Ottobock 4r104=60, 4r104=75 Slide Adapter Instruction Manual

4R104=60, 4R104=75

Product description

INFORMATION
Date of last update: 2021-07-05
► Please read this document carefully before using the product and observe the safety notices.
► Instruct the user in the safe use of the product.
► Please contact the manufacturer if you have questions about the product or in case of problems.
► Report each serious incident related to the product to the manu­ facturer and to the relevant authority in your country. This is par­ ticularly important when there is a decline in the health state.
► Please keep this document for your records.
1.1 Construction and Function
The 4R104=60 and 4R104=75 double adapters, sliding, are used to connect 2 pyramid adapters. The pyramid receivers make it possible to make distal and proximal angle adjustments of the prosthetic com­ ponents in the frontal and sagittal planes. The dovetail guide makes it possible to shift the prosthetic components in the frontal and sagittal
planes.
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.

Intended use

2.1 Indications for use
The product is intended exclusively for lower limb exoprosthetic fit­ tings.
2.2 Area of application
Approved for a body weight of up to 100 kg.
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
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 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.

Safety

3.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
3.2 General safety instructions
CAUTION!

Risk of injury and risk of product damage
► Note the combination possibilities/combination exclusions in the instructions for use of the products.
► Comply with the product’s field of application and do not expose it to excessive strain (see page 7).
► Do not expose the product to prohibited environmental condi­ tions.
► Check the product for damage if it has been exposed to prohib­ ited environmental conditions.
► Do not use the product if it is damaged or in a questionable con­ dition. Take suitable measures (e.g. cleaning, repair, replace­ ment, inspection by the manufacturer or a specialist workshop).
► To avoid the risk of injury and product damage, do not use the product beyond the tested lifetime.
► To avoid the risk of injury and product damage, only use the product for a single patient.
► To prevent mechanical damage, use caution when working with the product.
► If you suspect the product is damaged, check it for proper func­ tion and readiness for use.
► Do not use the product if its functionality is restricted. Take suit­ able measures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop).
Signs of changes in or loss of functionality during use Among other factors, changes in functionality can be indicated by an altered gait pattern, a change in the positioning of the prosthetic com­ ponents relative to each other and by the development of noises.

Scope of delivery

Preparing the product for use

CAUTION
Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components
► Observe the alignment and assembly instructions.
CAUTION
Improper assembly of the screw connections
Risk of injury due to breakage or loosening of the screw connec­ tions
► Clean the threads before every installation.
► Apply the specified torque values.
► Follow the instructions regarding the length of the screws and about how to secure the screws.

5.1 Installation in the modular prosthesis
Adjusting the stop
The set screw in the dovetail guide limits sliding of the adapter in one direction. For sliding in the opposite direction, the adapter can be turned or the set screw can be moved.
> Required tools: 710D20 torque wrench
► CAUTION! Only use the adapter with the set screw screwed into the dovetail guide.
Make sure that the set screw (see fig. 3) is screwed correctly into the dovetail guide (tightening torque: 5 Nm).
Connecting the pyramid adapter and pyramid receiver
The pyramid adapter is fixed with the set screws of the pyramid receiv­ er.
> Required materials: torque wrench (e.g. 710D20), 636K13 Loc­ tite 241

1. Fitting:
   Screw in the set screws.
   Use the torque wrench to tighten the set screws (10 Nm).
2. Definitive assembly:
   Secure the set screws with Loctite.
   Screw in the set screws.
   Pre-tighten the set screws with the torque wrench (10 Nm) and then tighten them (15 Nm).
3. Replace any set screws that are protruding or are recessed too much with appropriate set screws (see selection chart).

Replacement and disassembly
The set position of the prosthetic component can be maintained dur­ ing replacement or disassembly. In order to do this, unscrew the two set screws that are screwed in the furthest and located next to each other.
5.2 Adjusting adapter
> Required tools: 710D20 torque wrench
> Prerequisite: No load on the prosthesis and the prosthesis is not being worn.

1. Loosen the cap screws of the dovetail guide (see fig. 1).
2. Slide the adapter to the desired position.
3.  Tighten the cap screws (installation torque: 15 Nm).

Cleaning

1. Clean the product with a damp, soft cloth.
2. Dry the product with a soft cloth.
3. Allow to air dry in order to remove residual moisture.

 Maintenance

► A visual inspection and functional test of the prosthetic compon­ ents should be performed after the first 30 days of use.
► Inspect the entire prosthesis for wear during normal consulta­ tions.
► Conduct annual safety inspections.

Disposal

In some jurisdictions it is not permissible to dispose of the product with unsorted household waste. Improper disposal can be harmful to health and the environment. Observe the information provided by the responsible authorities in your country regarding return, collection and disposal procedures.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.
9.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descriptions and instructions provided in this document. The manufacturer will not assume liability for damage caused by disregarding the information in this document, particularly due to improper use or unauthorised modification of the product.
9.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of conformity can be down­ loaded from the manufacturer’s website.
9.3 Warranty
The manufacturer warrants this device from the date of purchase. The warranty covers defects that can be proven to be a direct result of flaws in the material, production or construction and that are reported to the manufacturer within the warranty period. Further information on the warranty terms and conditions can be obtained from the competent manufacturer distribution company.

Technical data

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Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt · Germany
T +49 5527 848-0 · F +49 5527 848-3360
[email protected]
· www.ottobock.com
© Ottobock · 647G1620=all_INT-22-2107