ottobock 1H38 Single Axis Foot only Men 10mm Toes Instruction Manual

: June 3, 2024
: ottobock

ottobock 1H38 Single Axis Foot only Men 10mm Toes

Instructions for use

Product description

INFORMATION
Date of last update: 2021-07-02

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 1H38 and 1H40 single axis 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.

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 exports’ hectic fittings. The product is suitable for fittings of geriatric patients.

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).

The product must be used in TF prostheses only.

The maximum approved body weight is specified in the technical data (see page 15).
The bilateral use of 1H* prosthetic feet imposes stricter requirements for the user’s balance.

Environmental conditions

Allowable environmental conditions

Temperature range for use: -10 °C to +60°C
Allowable relative humidity 0 % to 90 %, non-condensing
Unallowable environmental conditions

Mechanical vibrations or impacts
Perspiration, urine, fresh water, salt water, acids
Dust, sand, highly hygroscopic particles (e.g. talcum)
Other environmental conditions

UV light| Not resistant
Other environmental conditions

Hydrolysis| Not resistant

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

CAUTION
Warning regarding possible risks of accident or injury.

NOTICE
Warning regarding possible technical damage.

General safety instructions

Risk of injury and risk of product damage

Comply with the product’s field of application and do not expose it to excessive strain (see page 10).
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.
Note the combination possibilities/combination exclusions in the instructions for use of the products.

NOTICE!
Risk of product damage and limited functionality

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

Scope of delivery

Quantity	Designation
1	Instructions for use
1	Prosthetic foot

1H38, 1H40
Spare parts/accessories (not included in the 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.

Installing the foot adapter

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

Alignment

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

Do not grind the prosthetic foot.

Bench Alignment
TF bench alignment

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

Static Alignment

Otto bock 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 Otto bock.

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 foothill 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

The prosthetic components should be inspected 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

1H38

Sizes [cm]| 21| 22| 23| 24| 25| 26| 27| 28
Heel height [mm]| 10 ±5
System height with 2R33/2R10 [mm]| 42| 43| 44| 45| 46| 47
Build height with 2R33/2R10 [mm]| 60| 61| 62| 63| 64|
System height with 2R51 [mm]| 46| 47| 48| 49| 50| 51
Build height with 2R51 [mm]| 64| 65| 66| 67| 68|
Product weight without adapter [g]| 255| 275| 305| 335| 360| 365| 420| 435
Max. body weight [kg]| 100
Mobility grade| 1
1H40

Sizes [cm]| 22| 23| 24| 25| 26| 27| 28| 29
Heel height [mm]| 25 ±5
System height with 2R33/2R10 [mm]| 43| 44| 45| 46| 47| 51
Build height with 2R33/2R10 [mm]| 61| 62| 63| 64| 65| 69
System height with 2R51 [mm]| 47| 48| 49| 50| 51| 55
Build height with 2R51 [mm]| 65| 66| 67| 68| 69| 73
Product weight without adapter [g]| 295| 305| 320| 370| 400| 440| 470| 530
Max. body weight [kg]| 100
Mobility grade| 1

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