ottobock 1D10 Dynamic Foot with Toes Instruction Manual

: June 12, 2024
: ottobock

ottobock 1D10 Dynamic Foot with Toes

Product Description

INFORMATION

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

The 1D10 and 1D11 prosthetic feet are suitable for use in both modular and exoskeletal prostheses. The functional properties are achieved through the combination of a contoured core and functional foam.
The 1D10 prosthetic foot is available either without a foot adapter or with a preinstalled titanium foot adapter. An ankle block can only be installed without the preinstalled foot adapter.

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.

Allowable ankle blocks and screw connections

Reference number (prosthetic foot)| Foot size [cm]| Reference number

(ankle block and screw connection)

1D10 (without adapter)| All sizes| 2K34 and 2Z22=M10
1D11| 22 to 25| 2K34 and 2Z22=M8x90
26 to 28| 2K34* and 2Z22=M10
Allowable foot adapters

Reference number

(prosthetic foot)

| Foot size

[cm]

| Reference number

(foot adapter)

1D10 (without adapter)| All sizes| 2R8=M10, 2R31=M10,

2R54=M10

1D11| 22 to 25| 2R8=M8, 2R31=M8,

2R54=M8

26 to 28| 2R8=M10, 2R31=M10,

2R54=M10

Intended Use

Indications for use

The product is intended exclusively for lower limb exoprosthetic fittings.

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 1 (indoor walker) and mobility grade 2 (restricted outdoor walker).

The maximum approved body weight is specified in the technical data.

Environmental conditions

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)
Other environmental conditions

UV light| Not resistant
Hydrolysis| Not resistant
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

Lifetime

The product was tested by the manufacturer with 2 million load cycles. Depending on the user’s activity level, this corresponds to a maximum lifetime of 3 years.

Safety

Explanation of warning symbols

Warning regarding possible risks of accident or injury.

Warning regarding possible technical damage.

General safety instructions

Risk of injury and risk of product damage

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.
Comply with the product’s field of application and do not expose it to excessive strain.
Note the combination possibilities/combination exclusions in the instructions for use of the products.

Risk of product damage and limited functionality

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).
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
Decreased forefoot resistance or changes in roll-over behaviour are noticeable indications of loss of functionality.

Scope of Delivery

Quantity	Designation
1	Instructions for use
1	Prosthetic foot

Spare parts/options (not included in the scope of delivery)

Designation| Reference number
Connection plate| 2R14
Only for 1D10 without adapter and for 1D11
Foot adapter with screw connection| 2R8, 2R31, 2R54
Ankle block (exoskeletal design)| 2K34=
Screw connection for ankle block (exo skeletal design)| 2Z22=M8x90,
2Z22=M10
Ottobock special adhesive with hardener| 636W28 or 636W18 and 636W19

Preparing The Product For Use

Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components

Observe the alignment and assembly instructions.

Grinding the prosthetic foot
Premature wear resulting from damage to the prosthetic foot

Do not grind the prosthetic foot.

Installing the foot adapter or ankle block

The installation must be performed if the prosthetic foot is not equipped with a foot adapter or ankle block.

Installing the foot adapter

Install the foot adapter on the prosthetic foot according to its instructions for use.

Installing the ankle block (exoskeletal design)

Required materials : Screw connection (see page 10), 710D4 torque wrench, 40 grit sandpaper, 617H21 sealing resin, 617P37 hardener powder, suitable solvent (e.g. 634A28), only for 1WR95: 636W17 plastic adhesive

Insert the threaded socket of the screw connection in the proximal side of the hole in the ankle block.
Insert the screw on the foot sole side in the prosthetic foot and screw the ankle block to the prosthetic foot (mounting torque: 30 Nm).
Conduct the fitting of the ankle block.
Loosen the screw connection between the prosthetic foot and the ankle block.
Sand the ankle block according to the contour of the prosthetic foot.
Roughen the connection surface of the prosthetic foot in an a – p direction using the sandpaper.
Remove the dust from the sanded surfaces.
Mix the sealing resin with 2% to 3% hardener powder for the connection between the ankle block and the prosthetic foot.
INFORMATION : Do not put the resin in the hole for the screw connection.
Apply the resin evenly to the connection surfaces of the ankle block and prosthetic foot. At least 2 applications are required due to the absorbency of the wood.
When the resin is slightly cured (threads on the spatula), align the ankle block and prosthetic foot with each other.
Insert the screw on the foot sole side in the prosthetic foot and screw the ankle block to the prosthetic foot (mounting torque: 30 Nm).
Wipe off resin that comes out of the joint using a cloth.
1WR95 only: Apply plastic adhesive to the plug for the screw connection and press it fully into the prosthetic foot.
Remove any remnants of the adhesive using a suitable solvent.
Allow the adhesive to cure.

Alignment

Bench Alignment

TT bench alignment

Bench alignment process

Required materials: 662M4 goniometer, 743S12 heel height measuring apparatus, 743A80 50:50 gauge, alignment apparatus (e.g. 743L200 L.A.S.A.R. Assembly or 743A200 PROS.A.

Assembly)

Perform the assembly and alignment of the prosthetic components in the alignment apparatus according to the following specifications:
Sagittal plane
1| Heel height: Effective heel height (shoe heel height – sole thickness of forefoot) + 5 mm
2| Exterior foot rotation: approx. 5°
3| Anterior placement, middle of the prosthetic foot to the alignment reference line: 30 mm
4| Connect the prosthetic foot and prosthetic socket using the chosen adapters. The instructions for use of the adapters must be observed.
5| Determine the centre of the prosthetic socket with the 50:50 gauge. Align the prosthetic socket centrally to the alignment reference line.
Socket flexion: Individual residual limb flexion + 5°
6| Alignment reference line of prosthetic foot: between big toe and second toe
Alignment reference line of prosthetic socket: along the lateral patella edge
7| Observe the abduction or adduction position.

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.
If necessary, the alignment recommendations (TF modular leg prostheses: 646F219, TT modular leg prostheses: 646F336) may be requested from Ottobock.

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.
Remove the plastic protector from the pyramid after completing the dynamic fitting and the walking exercises.

Optional: Installing the foam cover

The foam cover sits between the prosthetic socket and prosthetic foot. It is cut longer in order to compensate for the movements of the prosthetic foot and prosthetic knee joint. During flexion of the prosthetic knee joint, the foam cover undergoes posterior compression and anterior elongation. The foam cover should be stretched as little as possible in order to increase its service life. There is a connecting element (such as a connection plate, connection cap or connection cover) on the prosthetic foot.

Required materials: degreasing cleaner (e.g. 634A58 isopropyl alcohol), 636N9 contact adhesive or 636W17 plastic adhesive

Measure the length of the foam cover on the prosthesis and add the length allowance. TT prostheses: Distal allowance for movement of the prosthetic foot. TF prostheses: Allowance proximal of the knee rotation point for flexion of the prosthetic knee joint and distal allowance for movement of the prosthetic foot.
Cut the pre-shaped foam cover to length and fit it in the proximal area on the prosthetic socket.
Pull the foam cover over the prosthesis.
Set the connecting element onto the footshell or prosthetic foot. Depending on the version, the connecting element engages in the edge or rests on the foot adapter.
Install the prosthetic foot on the prosthesis.
Mark the outer contour of the connecting element on the distal face of the foam cover.
Disassemble the prosthetic foot and remove the connecting element.
Clean the connecting element using a degreasing cleaner.
Glue the connecting element onto the distal face of the foam cover according to the marked outer contour.
Let the glue dry (approx. 10 minutes).
Install the prosthetic foot and adapt the exterior cosmetic shape.
Take into account compression caused by cosmetic stockings or Super Skin.

Cleaning

Clean the product with a damp, soft cloth.
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.
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.

Technical Data

1D10

Sizes [cm]

| 22| 23| 24| 25| 26| 27| 28| 29| 30
Heel height

[mm]

| 10 ±5
1D10
Sizes [cm]| 22| 23| 24| 25| 26| 27| 28| 29| 30
System height with adapter [mm]| 55| 58| 61| 64| 67| 70| 72| 74| 76
Build height with adapter [mm]| 73| 79| 79| 82| 85| 88| 90| 92| 94
Product weight without adapter [g]| 29
0| 32
0| 35
0| 39
0| 47
0| 50
5| 56
5| 60

5

| 68
5
Max. body weight [kg]| 125
Mobility grade| 1 and 2
1D10 with pre-installed foot adapter

Sizes [cm]| 22| 23| 24| 25| 26| 27| 28| 29| 30
Heel height

[mm]

| 10 ±5
System height

[mm]

| 55| 58| 61| 64| 67| 70| 72| 74| 76
Build height

[mm]

| 73| 76| 79| 82| 85| 88| 90| 92| 94
Product weight

without foot shell [g]

| 38
5| 41
5| 44
5| 48
5| 56
5| 60
0| 66
0| 70
0| 78
0
Max. body

weight [kg]

| 150
Mobility grade| 1 + 2
1D11

Sizes [cm]| 22| 23| 24| 25| 26| 27| 28
Heel height [mm]| 20 ±5
Sizes [cm]| 22| 23| 24| 25| 26| 27| 28
System height with adapter [mm]| 55| 58| 61| 64| 67| 70| 72
Build height with adapter [mm]| 73| 76| 79| 82| 85| 88| 90
Product weight without adapter [g]| 28
5| 29
0| 34
5| 37
5| 43
5| 49
5| 54
5
Max. body weight [kg]| 100| 125
Mobility grade| 1 and 2