ottobock LP2-W2 Freestyle Swim Instruction Manual

: June 13, 2024
: ottobock

ottobock LP2-W2 Freestyle Swim

ottobock LP2-W2 Freestyle Swim

Product description

INFORMATION

Date of last update: 2021-10-13

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

This document applies to the following products: LP2-W2 Freestyle Swim The prosthetic foot has carbon spring elements. The heel stiffness can be increased with a heel wedge.
The ankle joint of the prosthetic foot can be fixed in two positions: 0° plantar flexion for walking and 70° plantar flexion for swimming.

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.

Figures

Figures
Figures

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 appropriate modular connectors.

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 table that follows shows the suitable spring stiffness of the prosthetic foot, matching the patient’s body weight and activity.

Spring stiffness relative to body weight and activity level

Body weight [kg]| Low| Normal| High
44 to 52| 1| 1| 2
53 to 59| 1| 2| 3
60 to 68| 2| 3| 4
69 to 77| 3| 4| 5
78 to 88| 4| 5| 6
89 to 100| 5| 6| –
101 to 116| 6| –| –

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)
Chemicals/liquids: fresh water, salt water, perspiration, urine, soapsuds, chlorine water
Moisture: Submersion: max. 1 h in 3 m depth, relative humidity: no restrictions
Solids: Dust, occasional contact with sand
Clean the product after contact with humidity/chemicals/solids, in order to avoid increased wear and damage.

Unallowable environmental conditions

Solids: Highly hygroscopic particles (e.g. talcum), continuous contact with sand
Chemicals/liquids: Acids, continuous use in liquid media

Lifetime

Prosthetic foot

Depending on the patient’s activity level, the maximum lifetime of the product is 3 years.

Foot shell, protective sock

The product is a wear part, which means it is subject to normal wear and tear.

Safety

Explanation of warning symbols

CAUTION Warning regarding possible risks of accident or injury
NOTICE Warning regarding possible technical damage.

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 14).
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 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).

NOTICE

Risk of product damage and limited functionality

Check the product for damage and readiness for use prior to each 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).
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).

Signs of changes in or loss of functionality during use

Reduced spring effect (e.g. decreased forefoot resistance or changed rollover behaviour) or delamination of the spring are indications of loss of functionality. Unusual noises can indicate a loss of functionality.

Scope of delivery

Quantity	Designation	Reference number
1	Instructions for use	–
1	Prosthetic foot	–
1	Protective sock (black)	S0-NPS-200*
1	Heel wedge set	KIT-00-11*
1	Ankle cover	KIT-00-20000-00

Additional accessories/spare parts (not included in the scope of delivery)

Designation| Reference number
Footshell (without cap)| FTC-3C-1*
Tool to change the footshell| ACC-00-10300-00
Protective sock (white)| SL=Spectra-Sock

Preparing the product for use

CAUTION

Incorrect alignment, assembly or adjustment

Injury due to incorrectly installed or adjusted as well as damaged prosthetic components

Observe the alignment, assembly and adjustment instructions.

NOTICE

Grinding the prosthetic foot or foot shell

Premature wear resulting from damage to the product

Do not grind the prosthetic foot or foot shell.

Alignment

INFORMATION

There is a plastic protector on the product’s pyramid. It protects the connecting section from scratches during the alignment and fitting of the prosthesis.

Remove the protector before the patient leaves the workshop/fitting area.

Applying/removing the footshell

INFORMATION

Pull the protective sock over the prosthetic foot to prevent noises in the footshell.
Always use the prosthetic foot with the foot shell.
Apply or remove the foot shell as described in the foot shell instructions for use.

Bench Alignment

TT bench alignment

Bench alignment process

Required materials: 662M4 goniometer, 743S12 heel height measuring device,
743A80 50:50 gauge, alignment tool (e.g. 743L200 L.A.S.A.R. Assembly or 743A200 PROS.A. Assembly)
Assemble and align the prosthetic components in the alignment apparatus according to the following specifications:
1| Dorsiflexion/plantar flexion: Adjust the prosthetic foot to the heel height of the shoe. (The prosthetic foot is designed for shoes with a heel height of 10 mm.)
2| Adduction/abduction: Adjust the angle of the prosthetic socket in the front al plane.
3| Flexion/extension: Adjust the angle of the prosthetic socket in the sagittal plane.
4| Linear shifting of the prosthetic socket: Shift the prosthetic socket so that the plumb line runs along the front edge of the adapter on the prosthetic foot (see fig. 2).

TF bench alignment

Observe the information in the prosthetic knee joint instructions for use.

Static Alignment

Ottobock recommends checking the alignment of the prosthesis using the L.A.S.A.R. Posture and adapting it as needed.

Dynamic Trial Fitting

Adapt the alignment of the prosthesis in the frontal plane and the sagittal plane (e.g. by making angle or slide adjustments) to ensure an optimum gait pattern.
TT fittings: Make sure that physiological knee movement in the sagittal and frontal plane is achieved when the leg begins to bear weight after the heel strike. Avoid medial movement of the knee joint. If the knee joint moves in the medial direction in the first half of the stance phase, move the prosthetic foot in the medial direction. If the medial movement occurs in the second half of the stance phase, reduce the exterior rotation of the prosthetic foot.
Remove the plastic protector from the pyramid after completing the dynamic fitting and the walking exercises.

Heel too soft

Symptoms| Possible solutions

Foot makes full ground contact too quickly
Forefoot feels too stiff
Knee goes into hyperextension

|

Shift prosthetic socket forward relative to the foot
Use a heel wedge

Heel too hard

Symptoms| Possible solutions

Fast knee flexion, low stability
Transition from heel strike to toe-off too fast
Energy return feels low

|

Shift prosthetic socket back relative to the foot
Reduce the heel stiffness (shift or remove heel wedge)

Prosthetic foot too stiff

Symptoms| Possible solutions

Minimal rollover movement of the pros the tic foot at low walking speed (long full ground contact)

|

Select prosthetic foot in lower stiffness

Prosthetic foot too soft

Symptoms| Possible solutions

Clicking noise at the start of ground contact.

|

Select prosthetic foot in higher stiff ness
Very pronounced deformation of the forefoot at high activity levels

|

Optimising the heel characteristics
The behaviour of the prosthetic foot at heel strike and during heel contact in the mid-stance phase can be adapted with the placement of a heel wedge.
The heel wedge is attached with adhesive tape for testing. For definitive assembly, it is glued to the prosthetic foot.

Fitting

Place the double-sided adhesive tape (included) on the underside of the heel wedge.
Place the heel wedge on the base spring in the recommended position.
Optional: Shorten the heel wedge on the top if the heel strike is too hard.

Definitive assembly

Remove the adhesive tape from the heel wedge. This can be done using a cloth with acetone.
Roughen the contact surface on the prosthetic foot slightly using sandpaper. Remove the dust after sanding.
Glue the heel wedge to the prosthetic foot with contact cement.

Use

CAUTION

Unlocking the ankle joint
Risk of injury due to movement in the ankle joint of the prosthetic foot

Before using the prosthetic foot, make sure that the ankle joint is locked.
Always use 0° plantar flexion for walking.

Prerequisite: The prosthetic foot is not under load (for example, sitting or in the water).

Press the release button and flex the prosthetic foot in the desired direction.
→ When 0° or 70° plantar flexion is reached, the ankle joint locks and the release button springs back to the initial position.
Move the prosthetic foot up and down to verify that the ankle joint is locked.

Cleaning

Allowable cleaning agent: pH neutral soap (e.g. 453H10 Derma Clean)

NOTICE! To avoid product damage, only use the allowable cleaning agents.
Clean the product with clear fresh water and a pH neutral soap.
If present: Remove dirt from water drainage contours using a toothpick and rinse.
Rinse the soap away with clear fresh water. In doing so, rinse the footshell until all dirt has been removed.
Dry the product with a soft cloth.
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.
Inspect the product for visible damage every six months. Make additional inspection appointments as needed (e.g. for highly active or heavy users).

Changing the ankle cover

The ankle cover of the prosthetic foot has to be changed when it becomes worn. The new cover is inserted into the two grooves in the prosthetic foot’s ankle element and glued into place.

Required materials: Degreasing cleaner (e.g. acetone), sandpaper, Loctite 410

Take the old ankle cover off the prosthetic foot and remove all residue.
Using sandpaper, remove adhesive residue and slightly roughen the two grooves in the prosthetic foot’s ankle element.
Clean the inside of the new ankle cover with degreasing cleaner to improve the adhesion of the adhesive.
Carefully pull the new ankle cover over the prosthetic foot. Leave the two grooves exposed.
Apply Loctite 410 to the lower groove around the circumference of the ankle element.
Carefully pull the ankle cover into the lower groove until it fits correctly.
Apply Loctite 410 to the upper groove around the circumference of the ankle element.
Carefully pull the ankle cover into the upper groove until it fits correctly.
Remove excess adhesive.
Allow the adhesive to cure fully.

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.

Technical Data

LP2-W2 Freestyle Swim

Sizes [cm]| 22| 23| 24| 25| 26| 27| 28| 29| 30| 31
Heel height [mm]| 10
System height [mm]| 69| 85| 93
Build height [mm]| 87| 103| 111
Average weight with footshell [g]| 690| 860| 980
Max. body weight [kg]| 116
Mobility grade| 2, 3, 4

Customer Support

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

Otto Bock HealthCare LP
3820 West Great Lakes Drive
Salt Lake City, UT 84120
· USA
T +1 800 328 4058
·
F +1 800 655 4963
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