ottobock 4R88 Sliding Adapter Instruction Manual

ottobock 4R88 Sliding Adapter

Product description

INFORMATION
Date of last update: 2021-06-01

• 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 manu­facturer and to the relevant authority in your country. This is par­ticularly important when there is a decline in the health state.
• Please keep this document for your records.

Construction and Function
Sliding tube clamp adapters permit translation adjustments at the proximal end of a tube adapter. It therefore permits the distal compon­ents 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

Combination possibilities
This prosthetic component is compatible with Ottobock’s system of modular connectors. Functionality with components of other manufac­turers that have compatible modular connectors has not been tested.

Intended use

Indications for use
The product is intended exclusively for lower limb exoprosthetic fit­tings.

Area of application

• The maximum approved body weight is specified in the technical data (see page 9).
• 4R88 : Only use the product for TF prostheses directly below the prosthetic knee joint.

Ottobock recommends the use of structural components with a dia­meter of 34 mm when elevated loads are expected (e.g. for a transtibi­al prosthesis).

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)

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

Explanation of warning symbols

General safety instructions
Risk of injury and risk of product damage

CAUTION!

• Comply with the product’s field of application and do not expose it to excessive strain (see page 6).
• Note the combination possibilities/combination exclusions in the instructions for use of the products.
• Do not expose the product to prohibited environmental conditions.
• Check the product for damage if it has been exposed to prohibited environmental conditions.
• Do not use the product if it is damaged or in a questionable condition. Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop).
• Observe the maximum lifetime of the product.
• To prevent mechanical damage, use caution when working with the product.
• If you suspect the product is damaged, check it for proper function and readiness for use.
• Do not use the product if its functionality is restricted. Take suitable 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 components relative to each other and by the development of noises

Scope of delivery

Quant­

ity

| Designation| Reference number
---|---|---
1| Instructions for use| –
1| Adapter| –
1| Cap screw| 501Z2=M4x22
2| Clamping screw| 501Z16
4| Set screw| 506G3=M8x16
1| Set screw| 506G3=M5x8

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
Incorrect mounting of the tube Risk of injury due to breakage of load-bearing components Slide the tube all the way to the stop in the intended prosthetic component when mounting.

CAUTION
Improper assembly of the screw connections Risk of injury due to breakage or loosening of the screw connections

• 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.

Mounting the adapter
Required materials: torque wrench (e.g. 710D20), degreasing cleaner (e.g. acetone), 636K13 Loctite 241

1. Loosen the tube clamp cap screw by two turns.
2. For final assembly : Degrease the insertion range of the tube clamp adapter and tube adapter.
3. Insert the tube adapter fully into the tube clamp adapter up to the stop. Align the clamping slot: Tube clamp adapter: anterior Tube clamp adapter, sliding: anterior or medial
4. 4WR95=3 only: Apply Loctite to the tube clamp cap screw.
5. Tighten the cap screw (tightening torque according to thread diameter: M4: 5 Nm, M5: 10 Nm, M6: 13 Nm).

Installation in the modular prosthesis

• Required materials: torque wrench (e.g. 710D20), 636K13 Loctite 241
• Install the other prosthetic components as described in the respective instructions for use.

Adjusting adapter
The proximal section of the adapter is movable in a dovetail guide. A set screw acts as a stop. It is fastened in the desired position.

Adjusting the stop
Recommended materials: Torque wrench, e.g. 710D20

CAUTION! Use the adapter only with the set screw screwed in! Install the set screw in the desired position (tightening torque: 5 Nm).

Repositioning the adapter

• Recommended materials: Torque wrench, e.g. 710D20
• No load on the prosthesis, or the prosthesis is not being worn.
  • Loosen the two clamping screws of the dovetail guide (see fig. 1).
  • Move the proximal section of the tube clamp adapter in the dovetail guide. Note the maximum displacement (see fig. 2).
  • Tighten the two clamping screws (tightening 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 components should be performed after the first 30 days of use.
• Inspect the entire prosthesis for wear during normal consultations.
• 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.

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.

CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of conformity can be down­loaded from the manufacturer’s website.

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

Ottobock SE & Co. KGaA Max-Näder-Straße 15 · 37115 Duderstadt · Germany T +49 5527 848-0 · F +49 5527 848-3360 healthcare@ottobock.de · www.ottobock.com

References

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