ottobock 1E91 Runner Fitness Prosthetics Lower Limb Prosthetics Instructions

ottobock 1E91 Runner Fitness Prosthetics Lower Limb Prosthetics

DIMENSION

Transtibial

Transfemnral

Product description

• 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 1E91 Runner and 1E93 Runner junior prosthetic feet are intended for use in sports prostheses. The 1E93 Runner junior was designed for sports prostheses for children.
• The carbon spring contour provides high propulsion and low resistance. The prosthetic foot is also distinguished by its low weight.
• This document also contains information about the accessory products for the prosthetic foot (foot adapters, outer soles, protectors).

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.

• The prosthetic socket must be able to withstand the higher load­ing when practising sports.
  Permitted combinations

   | Designation| Reference number
  Outer soles and protect­ ors| 1E91| Runner sole| 2Z540=6
  Runner spike sole| 2Z541=6
  1E93| Runner junior sole| 2Z543=6
  Foot adapter| 1E91| Runner adapter with four-hole connector| 4R216=6
  Runner adapter with pyramid adapter, rotat­ ing| 4R218=6
  1E93| Runner junior adapter with pyramid adapter, rotating| 4R224=6
  Prosthetic knee joints| 1E91,

1E93

| Prosthetic sport knee joint| 3S80
Prosthetic sport knee joint with low viscosity oil| 3S80=1

• 1E91
  Only use prosthetic components approved for the respective sport or a body weight of 150 kg.

• 1E93
  Only use prosthetic components approved for the respective sport or a body weight of 100 kg.

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 22).

• The product is not suitable for the long jump or sports with a similar load on the prosthesis.

• 1E91
  This product is not suitable as an everyday prosthesis.

• 1E93

  • The product was developed for use in a children’s prosthesis.
  • This product is not suitable as an everyday prosthesis.
  • Approved for a body height up to max. 145 cm.

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
Chemicals/liquids: fresh water as dripping water, occasional contact with salty air (e.g. near the ocean)
Solids: dust
Prohibited environmental conditions

Chemicals/moisture: salt water, perspiration, urine, acids, soapsuds, chlorine water
Solids: dust in high concentrations (e.g. construction site), sand, highly hygroscopic particles (e.g. talcum)

Lifetime

• Prosthetic foot, foot adapter
• Recreational sports: The maximum lifetime is 3 years.
• Intensive use and competitive sports: The lifetime is 1 year.
• Outer sole, protector
  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

• The product may only be used by one person; reuse on another person is prohibited.

• Comply with the product’s field of application and do not expose it to excessive strain (see page 14).

• Note the combination possibilities/combination exclusions in the instructions for use of the products.

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

Scope of delivery

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

delivery)

Designation| Reference number
Hexagon socket screw (for foot adapter)| 501S89=M8X25

Preparing the product for use

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

• Observe the alignment and assembly instructions.

Selecting the stiffness

• 1E91
  Otto Bock recommends that the stiffness version is selected according to body weight and running style. Body weight| Long-distance running| Sprint
  ---|---|---
  Stiffness version
  40 kg to 50 kg

(90 lbs to 110 lbs)

| SPR-1| SPR-2
Body weight| Long-distance running| Sprint
---|---|---
Stiffness version
50 kg to 60 kg

(110 lbs to 130 lbs)

| SPR-2| SPR-3
60 kg to 72 kg

(130 lbs to 160 lbs)

| SPR-3| SPR-4
72 kg to 86 kg

(160 lbs to 190 lbs)

| SPR-4| SPR-5
86 kg to 104 kg

(190 lbs to 230 lbs)

| SPR-5| SPR-6

• 1E93
  The stiffness of the prosthetic foot is selected depending on the body weight. Body weight| Stiffness version
  ---|---
  15 kg to 20 kg (35 lbs to 44 lbs)| SPR-1
  20 kg to 25 kg (44 lbs to 55 lbs)| SPR-2
  25 kg to 30 kg (55 lbs to 66 lbs)| SPR-3
  30 kg to 37 kg (66 lbs to 81 lbs)| SPR-4
  37 kg to 45 kg (81 lbs to 100 lbs)| SPR-5

Mounting the adapter

The prosthetic foot is connected to the proximal prosthetic components with a connection adapter. The connection adapter is constructed in two parts.
The prosthetic foot is secured between the upper and lower adapter sections. The connection adapter has either a rotating pyramid adapter or a four-hole connector for mounting of a socket adapter. > Required tools: 710D20 torque wrench, 636K13 Loctite® 241

1. Set the upper section of the adapter onto the prosthetic foot. Align the adapter on the prosthetic foot in the middle of the scale.
2. Apply the lower section of the adapter on the opposite side.
3. Apply Loctite® to the 2 Allen head screws and install them (torque value: 12 Nm).

Installing the outer sole
CAUTION
Incorrect use of prosthetic foot and outer sole
Risk of injury due to lack of surface grip and damage to the product

• Only use the prosthetic foot with an outer sole.
• Only use outer soles with spikes on sports floors suitable for this purpose.

1. Apply Loctite 241 to the threads.
2.  Set the sole against the prosthetic foot.
3. Secure the sole with the screws provided.

Spike sole only: Installing spikes > Recommended tools: 710Z3 spike key

1. Using a spike key, screw the spikes completely into the threads on the outer sole and hand-tighten them.
2. Check the tightness of the spikes before each use.

Alignment

1. Bench Alignment
   INFORMATION
   The figures for the bench alignment can be found at the beginning of this document.
   INFORMATION
   For determining the overall system height of all prosthetic components for bench alignment, add 5-10 mm to the socket-floor measurement to compensate for the spring effect of the prosthetic foot. Use the larger value when the patient’s weight is at the upper limit of the maximum permissible patient weight.

   • TT bench alignment
     ** Bench alignment process**

     Required materials: 662M4 goniometer, 743A80 50:50 gauge, alignment apparatus (e.g. 743A200 PROS.A. Assembly)
     Perform the assembly and alignment of the prosthetic components in the alignment apparatus according to the following specifications:
     ****| Sagittal alignment prosthetic foot

a–p position of the reference point to the alignment reference line: See illustrations at the start of the document

****| Frontal alignment of prosthetic foot

Lateral rotation: 0° (see page 20)

****| Sagittal alignment pivot point knee joint

a–p position of pivot point to alignment reference line:

-15 mm

**|
Bench alignment process**

 | Connect the prosthetic foot and prosthetic socket using the chosen adapters. Be sure to follow the adapter instructions for use.

| Sagittal alignment prosthetic socket

In proximal area centred on alignment reference line

Socket flexion: Individual residual limb flexion + 5°

****| Observe the abduction or adduction position.

• TF bench alignment
  Bench alignment process

  Required materials: 662M4 goniometer, 743A80 50:50 gauge, alignment apparatus (e.g. 743A200 PROS.A. Assembly)
  Perform the assembly and alignment of the prosthetic components in the alignment apparatus according to the following specifications:
  ****| Sagittal alignment prosthetic foot

a–p position of the reference point to the alignment reference line: See illustrations at the start of the document

****| Frontal alignment of prosthetic foot

Lateral rotation: Specified by the prosthetic knee joint (see page 20)

****| Sagittal alignment prosthetic knee joint

a–p position of the reference point to the alignment reference line: -15 mm

****| Frontal alignment prosthetic knee joint

Lateral rotation: approx. 5°

| Connect the prosthetic foot and prosthetic socket using the chosen adapters. Be sure to follow the adapter instructions for use.
| Sagittal alignment prosthetic socket

In proximal area centred on alignment reference line

Socket flexion: Individual residual limb flexion + 5°

**| Observe the abduction or adduction position.
2. Static Alignment**

• Ottobock recommends checking the alignment of the prosthesis using the L.A.S.A.R. Posture and adapting it as needed.
• TT prostheses: The load line should run approx. 15 mm anterior to the compromise pivot point according to Nietert.
• TF prostheses: The load line should run approx. 40 mm anterior to the rotation axis of the prosthetic knee joint.

3. Dynamic Trial Fitting
   • Adapt the setup of the prosthesis in the frontal plane and the sagittal plane (e.g. by making angle or slide adjustments) so that optimal rollover is ensured.
   • TT fittings:Make sure that physiological knee movement is achieved after the leg begins to bear weight.
   • Adapting the alignment of the prosthetic foot (see page 20). The alignment of the prosthetic foot is optimised if it points straight forward when it is set down.

Aligning the prosthetic foot

• Moving
  The prosthetic foot can be shifted in the connection adapter. It is shifted on a radius which changes the angle of the heel strike and the dynamics of the prosthetic foot. The bench alignment remains unchanged, as moving does not have an effect in the a–p direction. Moving the prosthetic foot in anterior direction| Heel strike harder, more

aggressive

---|---
Moving the prosthetic foot in posterior direction| Heel strike softer, more relaxed

• Required tools: 241 636K13 Loctite®, 710D20 torque wrench

  1. Loosen the 2 Allen head screws on the underside of the adapter.  

The adapter can now be moved.

  2. Set the required position of the adapter.
  3.  Secure the 2 Allen screws with Loctite® and tighten (torque: 12 Nm).

• Turning
  Connection adapter with pyramid adapter only: The pyramid adapter can be rotated to any position. The pyramid adapter is fixed when the set screws of the adapter that is attached proximally are tightened.

  • Required tools: 241 636K13 Loctite®, 710D20 torque wrench
  1. Loosen the two set screws that are screwed in the furthest and located next to each other.
  2. If the pyramid adapter cannot be turned: Carefully tap the pyramid adapter from the top to loosen it. Set the desired rotation angle.
  3. Secure the set screws with Loctite® and tighten (for the required torque, see instructions for use of the respective adapter).

Cleaning

1. Rinse the product with clear fresh water.
2. Dry the product with a soft cloth.
3. 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 prosthesis 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.

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

1E91

Stiffness version| SPR-1| SPR-2| SPR-3| SPR-4| SPR-5
Build height [cm]| Approx. 30
Build height, under load [cm]| Approx. 27
Weight [g]| 460| 490| 515| 550| 585
Max. body weight [kg]| 50| 60| 72| 86| 104
1E93

Stiffness version| SPR-1| SPR-2| SPR-3| SPR-4| SPR-5
Structural height [cm]| approx. 18.5
Structural height, under load [cm]| approx. 16
Weight [g]| 170| 180| 190| 200| 210
Max. body weight [kg]| 20| 25| 30| 37| 45
Reference number| 4R216=6| 4R218=6| 4R224=6
---|---|---|---
Weight [g]| 175| 180| 175
System height [mm]| 13| 5| 3
Max. body weight [kg]| 125| 45
Reference number| 2Z540=6| 2Z541=6| 2Z543=6
---|---|---|---
Weight [g]| 160| 135| 90
Structural height [mm]| 15| 12| 13

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