ottobock 1E2 ProCarve Foot Standard Instruction Manual

1E2 ProCurve Foot Standard
Instruction Manual

Product description

INFORMATION
Date of last update: 2022-03-02

► 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.
1.1 Construction and Function
The ProCurve is a sports prosthesis solution for skiing, snowboarding, waterskiing, wakeboarding, or other sports with similar motions. The sports prosthesis solution comprises the 3R2 prosthetic knee joint and the 1E2 or 1E2=1 prosthetic foot. The prosthetic foot can also be used by itself for a TT sports prosthesis.
The prosthetic knee joint and the prosthetic foot feature adjustable shock absorbers. The function of the shock absorbers is to absorb impacts that occur when performing a sport. During flexion, a pneumatic spring provides the necessary resistance, whilst hydraulics damp movements in extension. The hardness of the pneumatic spring is
adjusted using a high-pressure air pump; the extension damping strength is controlled by a hydraulic valve. This enables the best settings for the chosen sport.
The 1E2=1 prosthetic foot is equipped with a polymer ring, which increases the flexion resistance further. This is practiced mainly for TT fittings.
The prosthetic knee joint can be unlocked in order to make sitting down more comfortable.

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

INFORMATION
The prosthetic socket must be able to withstand the higher loading of the sport.
Limited combination options for Ottobock components

Permitted combinations

| Reference number
Lamination anchor| 4R116=T, 4R119=T
Socket adapter| 4R54, 4R54=10, 4R77
Double adapter| 4R72=*
Tube clamp adapter| 4WR95=3
Tube adapter| 2WR95
Prosthetic foot| 1E2, 1E2=1
Prosthetic knee joint| 3R2

Intended use

2.1 Indications for use
The product is intended exclusively for lower limb endoprosthetic fittings.
The product is not suitable for use in everyday prostheses.
2.2 Area of application
Recommended for use in sports prostheses for skiing and snowboarding sports as well as waterskiing and wake­ boarding.
Approved for a body weight of up to 100 kg.
2.3 Environmental conditions

Allowable environmental conditions
Temperature range for use: -20 °C to +60°C
Allowable relative humidity: 0% to 90%, condensing
Allowable environmental conditions
Moisture: fresh water, salt water
Unallowable environmental conditions
Mechanical vibrations or impacts (except during sports)
Perspiration, urine, acids
Dust, sand, highly hygroscopic particles (e. g. talcum)

2.4 Lifetime
These prosthetic components were tested by the manufacturer for 3 million load cycles. Depending on the sport, this corresponds to a maximum lifetime of 5 years.

Safety

3.1 Explanation of warning symbols

WARNING
Warning regarding possible serious risks of accident or injury.
CAUTION
Warning regarding possible risks of accident or injury.
NOTICE
Warning regarding possible technical damage.
3.2 General safety instructions

WARNING!
Risk of severe injuries
► Only use the product after receiving instruction from qualified personnel. There is a risk of injury.
► Do not use the product as an everyday prosthesis.
► Your ability to swim is limited with the prosthesis. There is a risk of drowning. During water sports and swim­ ming, always wear an appropriate flotation device that is able to support your body weight together with the prosthesis.
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 18).
► 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).
► The product may only be used by one person; reuse on another person is prohibited.
► Maintain the product regularly to ensure a long lifetime (see page 24).
► To avoid the risk of pinching, do not reach into the joint mechanism.
► 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, replace­ ment, 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 position­ ing of the prosthetic components relative to each other and by the development of noises.

Scope of delivery

3R2 ProCurve prosthetic knee joint

see fig. 2 , item:| Quantity| Designation| Reference number
---|---|---|---
–| 1| Instructions for use| –
–| 1| Quick reference guide| 647G953
---|---|---|---
1| 1| Prosthetic knee joint| 3R2
2| 1| Knee blocking clip (black strap)| 4G115

1E2, 1E2=1 ProCurve prosthetic foot

see fig. 2 , item:| Quantity| Designation| Reference number
---|---|---|---
–| 1| Instructions for use| –
–| 1| Quick reference guide| 647G953
4| 1| Prosthetic foot with foot pads and ski soles| 1E2*
3| 1| In addition for 1E2: foot blocking clip (red strap)| 4G115=1
5| 1| Foot shell| 4G901
6| 1| High-pressure air pump| 755Y68

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

Designation| Reference number
Ski sole set| 2Z503=1

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.

CAUTION
Use of talcum
Risk of injury, damage to the product due to lack of lubrication
► Do not use talcum on the product or other prosthesis components.
INFORMATION
For a waterproof prosthesis, use titanium screws and set screws.
INFORMATION
The prosthesis alignment described and the air pressure values given represent basic values. They are to be adapted to the individual requirements of the patient.

The three-dimensional alignment of the prosthesis socket and the modular components affects the function of the prosthesis. The patient can use the properties of the sports prosthesis to their fullest potential only when the product is correctly aligned.
The residual limb position, e. g. abduction, adduction and flexion, must be considered when positioning the socket connector. It is recommended to align according to the patient’s everyday prosthesis.
Alignment is performed in 2 steps:

• Bench alignment
• Dynamic trial fitting

The sports prosthesis is individually adjusted during dynamic trial fitting at a sports facility. All the parameters are adjusted according to the requirements and ability of the patient during this fitting.
The 1E2* Prosthetic Foot is equipped for use in a ski binding as delivered. If the prosthetic foot is to be used in a snowboarding soft boot or another boot, the foot shell included in the scope of delivery must be attached before the bench alignment.
5.1 Optional: replacing socket adapters
The socket adapters on the prosthetic knee joint can be replaced. This can be done with the screws provided with the prosthetic knee joint and with a different tightening torque. Cap screws are also provided with the 4R54=10 Socket Adapter.

Required materials: 710D20 torque wrench, 636K13 Loctite, 501S84=M6x18 countersunk screws

1.  Remove the countersunk screws of the old adapter.
2.  Align the new adapter and position it on the prosthetic knee joint.
3.  Apply Loctite to the four screws and screw them in.
4. Tighten the posterior screws (10 Nm).
5. Tighten the anterior screws (10 Nm).

5.2 Optional: converting the prosthetic foot
Ski binding to foot shell

Required materials: 710D20 torque wrench, 4 mm and 5 mm Allen keys, foot shell, 636K13 Loctite, 501S71=M6x10 countersunk screws

1.  Loosen the four cap screws of the foot pad installed on the anterior side (see fig. 3, see fig. 4).
2. Remove the foot pad from the prosthetic foot (see fig. 5).
3. Loosen the four cap screws of the foot pad installed on the posterior side and remove the foot pad.
4.  Position the foot shell on the prosthetic foot.
5. Apply Loctite to the four countersunk screws and screw the foot shell in place (10 Nm) (see fig. 6).

Foot shell to ski binding

Required materials: 710D20 torque wrench, 4 mm and 5 mm Allen keys, foot pads for the ski binding, cap screws for the foot pads, 636K13 Loctite

1.  Loosen the four countersunk screws and remove the foot shell from the prosthetic foot (see fig. 6).
2.  Set the anterior foot pad onto the prosthetic foot (see fig. 5).
3. Apply Loctite to the two longer cap screws and screw them into the foot pad on the face side (10 Nm) (see fig. 4).
4. Apply Loctite to the two shorter cap screws and screw them into the foot pad on the sole side (10 Nm) (see fig. 3).
5. Install the posterior foot pad the same way.

5.3 Bench Alignment
TF bench alignment

Bench alignment process (see fig. 7 )

Required materials: 710D20 torque wrench, 636K13 Loctite, 4 mm Allen key
1| Place the prosthetic foot on the work surface.
2| Connect the prosthetic foot with a tube adapter and tube clamp adapter or a double adapter. Set the angle α for the chosen sport:
Skiing| Min. 75°| Max. 80°
Snowboarding| Min. 75°| Max. 85°
3| INFORMATION: Take the heel height of the ski boot or snowboard boot into consideration when position­ ing the alignment reference point.

Mount the prosthetic knee joint according to the instructions for use of the modular adapter.

Position the alignment reference point (rotation axis of the prosthetic knee joint) at the height of the medial tibial plateau to floor measurement + 20 mm.

4| Position the prosthetic socket on the prosthetic knee joint:
The tuberosity reference point at the height of the tuberosity-floor measurement
Set the angle β for the chosen sport and the movement style, taking the individual socket flexion into account.
Skiing and snowboarding| Min. 120°| Max. 160°
Use double adapters to compensate for any height difference due to increased knee flexion.
5| Check the prosthetic alignment during the dynamic fitting. Make corrections if necessary.

TT bench alignment
INFORMATION
Ottobock recommends a fitting with a thigh sleeve.

Bench alignment process (see fig. 7 )

Required materials: 710D20 torque wrench, 636K13 Loctite, 4 mm Allen key
1| Place the prosthetic foot on the work surface.
2| Connect the prosthetic foot with a tube adapter and tube clamp adapter or a double adapter.

Set the angle α for the chosen sport.

3

| Skiing| Min. 80°| Max. 85°
---|---|---|---
Snowboarding| Min. 80°| Max. 90°
4| INFORMATION: Take the heel height of the ski boot or snowboard boot into consideration when position­ ing the alignment reference point.
Position the prosthetic socket on the modular adapters:
Observe the MPT-floor measurement and length measurement of the everyday prosthesis
Align the prosthetic socket according to the knee angle, determined by the type of sport and the movement style. Take into account the individual socket flexion.
5| Check the prosthetic alignment during the dynamic fitting. Make corrections if necessary.

5.4 Dynamic Trial Fitting
During dynamic trial fitting, the alignment and settings of the prosthesis are checked. The flexion and extension movement damping is adjusted to the patient’s requirements.

Adjusting the flexion and extension damping

Required materials: High-pressure air pump, Allen wrench (3 mm)
1| The pneumatic springs in the shock absorber control the flexion of the prosthetic knee joint and the prosthetic foot. Their hardness is adjusted using the high-pressure air pump (see fig. 8).
Unscrew the valve cap on the shock absorber. Screw the air pump onto the valve.
Set the desired pressure. Note that 1 bar to 2 bar of pressure escapes when removing the air pump.
Unscrew the air pump from the valve and screw the valve cap back on.
Prosthetic foot
Skiing| TF| min. 5 bar| max. 15 bar
TT| min. 20 bar| max. 25 bar
Snowboarding| TF| min. 8 bar| max. 15 bar
TT| min. 15 bar| max. 25 bar
Prosthetic knee joint
Skiing| min. 8 bar| max. 15 bar
Snowboarding
2| The hydraulic valves control the extension damping (see fig. 9). The adjustment influences the speed of the pros­ thetic knee joint extension and the plantar flexion of the prosthetic foot.
Set the valve to the desired value using an Allen key ( 3 mm ).
Left stop ( – )| Minimum damping (factory setting)
Right stop ( + )| Maximum damping

Use

CAUTION
Overheating of the hydraulics due to excessive strain
Burns, injuries caused by falling due to changes in functionality, and damage to prosthetic components
► Do not touch overheated prosthetic components.
► Reduce all activities if there are changes in functionality, in order to allow the overheated prosthetic compo­ nents to cool down.
► If overheating or changes in functionality occur, have the prosthesis checked by an authorized qualified person­ nel.

NOTICE
Mechanical overload
Impaired functionality due to mechanical damage
► Check the product for damage prior to each use.
► Do not use the product if its functionality has been impaired.
► Take any necessary measures (e.g. repair, replacement, inspection by the manufacturer’s customer service, etc.).

INFORMATION
Leak in the product’s hydraulic system
Environmental damage or skin irritation due to leaking hydraulic oil
► Before each use, check the product for leaking hydraulic oil.
► In case of leaks, do not continue using the product and have it repaired promptly.

NOTICE
Incorrect ski binding adjustment for the ProCurve
Damage to the product due to improperly adjusted trigger value (Z value)
► Have your ski binding adjusted by a ski service shop.
► Adjust the weight to trigger the ski binding on the prosthesis side to the body weight minus 10 kg.
► The maximum trigger torque (Mz) is 100 Nm.

6.1 Unlocking and locking the prosthetic knee joint

The prosthetic knee joint can be unlocked in order to sit down. This enables a chairlift to be used, for example.
When standing up, the lock must be engaged again manually.
Flexion (unlocking)

Prerequisite: The prosthetic knee joint is extended and not under load.
► Pull the posterior strap on the prosthetic knee joint upwards in order to unlock the prosthetic knee joint (see fig. 12).
→ The prosthetic knee joint can now be flexed (see fig. 13, see fig. 14).

The extension (engaging the locking device)

CAUTION
The prosthetic knee joint is not completely extended
Risk of injury if the locking device is not engaged
► Before using the prosthesis, always check whether the locking device on the prosthetic knee joint has fully engaged.

Prerequisite: The prosthetic knee joint is flexed.

1.  Extend the prosthetic knee joint.
2. Engage the locking device by pressing it with your hand.
3. Prior to using, check whether the locking device is engaged.

6.2 Locking and unlocking the damping mechanism
Before walking, a blocking clip must be installed respectively on the damping mechanism of the prosthetic knee joint and the prosthetic foot. The blocking clips have to be removed again before skiing.
Locking the damping mechanism
> Prerequisite: The prosthesis is not under load.

1. Install the knee blocking clip (black strap) on the damping mechanism of the prosthetic knee joint (see fig. 10, see fig. 11).
2. Install the foot blocking clip (red strap) on the damping mechanism of the prosthetic foot.

Unlocking the damping mechanism

Prerequisite: The prosthesis is not under load.

1. Remove the knee blocking clip (black strap) from the damping mechanism of the prosthetic knee joint (see fig. 11, see fig. 10).
2.  Remove the foot blocking clip (red strap) from the damping mechanism of the prosthetic foot.

Cleaning

**CAUTION
Use of unsuitable cleaning agents or disinfectants**
Impairment of functionality and damage due to incorrect cleaning agents or disinfectants
► Only clean the product with the approved cleaning agents.
► Only disinfect the product with the approved disinfectants.
► Observe the instructions for cleaning and care.

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

1. Clean the product with clear fresh water and pH-neutral soap.
2.  Rinse the soap away with clear fresh water.
3. Dry the product with a soft cloth.
4. Allow to air dry in order to remove residual moisture.

Maintenance

CAUTION
Failure to follow the maintenance instructions
Risk of injuries due to changes in or loss of functionality and damage to the product
► Observe the following maintenance instructions.
► Following an individual period for the patient to get accustomed to the product, check the settings of the pros­ thesis and, if necessary, adapt them.
► Arrange regular maintenance intervals with the patient depending on the level of use.
► Inspect the entire prosthesis for wear during normal consultations.
► Conduct annual safety inspections.
► As part of the safety inspections, inspect the joints of the prosthesis for wear and proper functionality. Special attention should be paid to movement resistance, bearings, and abnormal noises. Full flexion and extension must be ensured at all times. Readjust as required.

8.1 Replacing the ski soles
> Required tools and materials:
Phillips screwdriver, 501B6=4.2×13 Oval-Head Screws

1. Unscrew the 4 screws in the ski sole that is to be replaced (see fig. 15).
2. Replace the ski sole and screw it in (see fig. 16).

Disposal

Dispose of the product in accordance with national regulations.

 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.
10.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descriptions and instruc­ tions 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 unauthorized modification of the product.
10.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of con­ formity can be downloaded from the manufacturer’s website.

Technical data

Prosthetic knee joint

Reference number| 3R2
Weight [g]| 1990
System height [mm]| 241
System height, distal [mm]| 207
System height, proximal [mm]| 34
Proximal connection| Pyramid adapter
Distal connection| Pyramid adapter
Max. flexion angle (unlocked) [°]| 80
Max. body weight [kg]| 100
Prosthetic foot

Reference number| 1E2| 1E2=1
Weight [g]| 1550
System height
–  with attachments for ski binding [mm] –  with foot shell [mm]| 120
103
Proximal connection| Pyramid adapter
Max. range of motion [°]| 25
Max. body weight [kg]| 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

Documents / Resources

| ottobock 1E2 ProCarve Foot Standard [pdf] Instruction Manual
1E2, ProCarve Foot Standard, 1E2 ProCarve Foot Standard
---|---

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