ottobock 1K10, 1K30, 1S30 Dynamic Foot for Children Instruction Manual
- June 4, 2024
- ottobock
Table of Contents
ottobock 1K10, 1K30, 1S30 Dynamic Foot for Children Instruction Manual
Product description
INFORMATION
Date of last update: 2021-09-14
- 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 1K10, 1K30 and 1S30 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 for children. 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 8).
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)
Other environmental conditions
UV light| Not resistant
Hydrolysis| Not resistant
Lifetime
This product has been load-tested by the manufacturer. The maximum lifetime is 2 years.
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
- Comply with the product’s field of application and do not expose it to excessive strain (see page 6).
- The product may only be used by one person; reuse on another person is prohibited.
- Note the combination possibilities/combination exclusions in the instructions for use of the products.
NOTICE!
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/accessories (not included in the scope of deliv ery)
Fig.| Item| Designation| Reference num ber
For 1K10 prosthetic feet size 14 – 17, 1K30 size 14 – 17, 1S30 size 12
– 13
2| 1| Foot adapter with screw connection| 2R40=2
For 1K10 prosthetic feet size 18 – 21, 1K30 size 18 – 21
2| 2| Foot adapter with screw connection| 2R40=1
Preparing the product for use
CAUTION
Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components
- Observe the alignment and assembly instructions.
Mounting the 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
Foot size| Mid-foot anterior to the alignment reference line|
Heel height
---|---|---
12 – 16 cm| 15 mm| see Technical Data
17 – 21 cm| 20 mm
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.
- 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.
Cleaning and Care
- 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.
- Have the prosthetic components inspected every 3 months.
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
| Reference number | 1K10 | 1K30 | 1S30 |
|---|---|---|---|
| Heel height [mm] | 5 ± 5 | 5 ± 5 | 10 ± 5 |
| Colours | Beige |
Size: 1, system height with adapter: 2, max. body weight [kg]: 3, weight: 4
1 [cm]| 12| 13| 14| 15| 16| 17| 18|
19| 20| 21
2 [mm]| 37| 40| 40| 42| 44| 46| 48| 50| 52| 54
3 [kg]| 35| 45
4 [g]|
1K10| –| –| 120| 130| 140| 155| 180| 210| 230| 255
1K30| –| –| 95| 115| 125| 175| 175| 180| 200| 220
1S30| 90| 100| –| –| –| –| –| –| –| –
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
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>