ottobock 7E8 Walking Prosthetic Hip Joint Instructions

ottobock 7E8 Walking Prosthetic Hip Joint Instructions

Scope of delivery

Technical data

Bench alignment of the prosthesis

Optimising the static alignment

Optimising during dynamic trial fitting

Finishing the prosthesis

Maintenance

1 Notes regarding the document

INFORMATION
Date of last update: 2021-10-21

► 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.

This document and the product are intended exclusively for the fabrication of a prosthesis by orthopaedic technicians with technical know ledge of lower limb prosthetic fittings.

1.1 Explanation of warning symbols

⚠ CAUTION Warning regarding possible risks of accident or injury.

NOTICE
Warning regarding possible technical damage.

2 Product description

The product (7E8) has the following key features:

• Monocentric prosthetic hip joint

• Product components for swing phase control:
  – Extensor (spring force adjustable)

• Material: Aluminium

3 Intended use

3.1 Indications for use

The product is intended exclusively for lower limb exoprosthetic fittings.

3.2 Area of application

⚠ CAUTION
Excessive strain on the product Fall due to breakage of load-bearing components
►Only use the product according to its allowable field of application.

Allowable field of application
Children’s prosthesis (Everyday prosthesis)

Allowable body weight
See item number in Figure 2 “Technical data” on page 3

Allowable body height
See item number in Figure 2 “Technical data” on page 3

Allowable foot size
See item number in Figure 2 “Technical data” on page 3

3.3 Combination possibilities

⚠ CAUTION
Improper combination of prosthetic components Injuries, malfunctions or product damage due to unallowable com bination of prosthesis components
► Based on the instructions for use of all prosthetic components used, verify that they may be combined with each other and are approved for the patient’s area of application.

INFORMATION
In a prosthesis, all prosthetic components have to meet the patient’s requirements regarding the amputation level, body weight, activity level, environmental conditions and field of application.

3.4 Environmental conditions

⚠ CAUTION
Use under unallowable environmental conditions Fall due to damaged product

► Do not expose the product to unallowable environmental conditions (see the table “Unallowable environmental conditions” in this section).
► If the product was exposed to unallowable environmental conditions, take suitable steps (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop etc.).

Allowable environmental conditions
Temperature range: -10 °C ­ +60 °C

Allowable environmental conditions U
se – Relative humidity: 0 % ­ 90 % (Non-condensing) Storage/Transportation – Relative humidity: 100 % Tyre pressure: 250 ­ 1100 mbar Commercially available, solvent-free cleaning agents

Unallowable environmental conditions Storage/Transportation: Mechanical vibrations, Impacts Hygroscopic particles (e.g. Talcum powder), Dust, Sand, Fresh water, Salt water, Acids, Sweat, Urine Cleaning agents containing solvents

3.5 Reuse and lifetime

⚠ CAUTION
Reuse on another patient
Fall due to loss of functionality as well as damage to the product
►Only use the product for a single patient.

⚠ CAUTION
Exceeding the lifetime Fall due to change in or loss of functionality and damage to the product
► Ensure that the maximum lifetime defined in this section is not exceeded.
This product has been load-tested by the manufacturer. The maximum lifetime is 2 years.

4 General safety instructions

⚠ CAUTION
Reaching into the area of the joint mechanism
Pinching of limbs (e.g. fingers) and the skin due to uncontrolled joint movement

► Do not reach into the joint mechanism during daily use.
► Close attention is required during assembly and adjustment tasks.

⚠ CAUTION
Mechanical damage to the product Risk of injury due to change in or loss of functionality

► Use caution when working with the product.
► If the product is damaged, check it for proper function and readiness for use.
► In case of changes in or loss of functionality, do not continue using the product (see “Signs of changes in or loss of functionality during use” in this section).
► Take any necessary measures (e.g. repair, replacement, inspection by the manufacturer’s customer service, etc.).

Signs of changes in or loss of functionality during use Changes in functionality can manifest themselves, for example, through a changed gait (swing phase, stance phase), incomplete extension, stiffness and the development of noise.

5 Scope of delivery

The scope of delivery is shown in Figure 1 on page 2. Only product components with reference numbers in the illustration can be reordered separately.

6 Technical data

The technical data are shown in Figure 2 on page 3. : System height (SH)

7 Preparing the product for use

7.1 Information on fabrication of a prosthesis

⚠ 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
Initial use of the prosthesis by the patient Fall due to lack of patient experience, incorrect alignment or incorrect adjustment of the prosthesis
▶ For the safety of the patient, use a suitable device (e.g. parallel bars, handrail, wheeled walker) during initial standing and walk ing.

7.2 Bench alignment of the prosthesis

INFORMATION
The prosthetic components and prosthesis shown in the illustrations are used as examples to illustrate the general process. The instructions for use of the prosthetic components selected for the patient contain detailed information and have to be used for fabrication of the prosthesis.

▶ CAUTION! To enable the patient to stand safely, align the pros thesis using the alignment images for the sagittal plane and front al plane (Figure 3 on page 4) as well as the instructions for use of all prosthetic components that were used.

Fabricating the pelvic socket ( 4 on page 5 ­ )
⚠ CAUTION
Failure to observe instructions regarding the lamination plate and pelvic socket Risk of falling due to breakage or deformation of the lamination plate and pelvic socket

► Follow all instructions in this section when fabricating the pelvic socket.
► Do not modify the lamination plate (e.g. by shortening or bending).
► Note that the section “Reuse and lifetime” also applies to the lamination plate.
► Manufacture the pelvic socket using the lamination plate in such a way as to ensure safe use with respect to the patient’s body weight and level of activity.

1. Before laminating, close the threaded holes in the lamination plate with 636K6 plasticine.
2. : For reinforcement, thread 699B1 fibreglass roving through the bores in the lamination plate and leave an overhang of about 4 cm.
3. : Reinforce the pelvic socket in the area of the lamination plate using 616G12 carbon fibre cloth (up to three layers, depending on the weight and height of the patient).

Installing the tube adapter ( 6 on page 7)
⚠ CAUTION
Incorrect processing of tube
Fall due to damage to the tube
► Do not clamp the tube into a vice.
► To shorten the tube, use only a tube cutter or a cutting device.

⚠ CAUTION
Incorrect mounting of the tube
Risk of injury due to breakage of load-bearing components
▶ Slide the tube all the way to the stop in the intended prosthetic component when mounting.

⚠ CAUTION
Improper assembly of the screw connections
Risk of injury due to breakage or loosening of the screw connections

► Clean the threads before every installation.
► Apply the specified torque values.
► Follow the instructions regarding the length of the screws and about how to secure the screws.
► Use the smallest value for the allowable insertion depth as the minimum insertion depth.
→ (1) : Allowable insertion depth: 0 mm
→ (2) : Unallowable insertion depth: > 0 mm

Product adjustment options
► If necessary, use the adjustment options shown in illustrations (5 on page 6 – : adjustable extension stop; 6 on page 7 –: rotation in the axis of the tube; 7 on page 8 – : abduction/adduction).

7.3 Optimising the static alignment

► To optimise the static alignment, position the patient on the measuring device.
► In the sagittal plane, check the course of the load line relative to the marked alignment reference point and correct this if needed (see Figure 8 on page 9).
► In the frontal plane, check the course of the load line relative to the marked points (prosthetic foot, prosthetic knee joint, spina ili aca anterior superior) and correct if needed (see Figure 8 on page 9).

7.4 Optimising during dynamic trial fitting

⚠ CAUTION
Adjusting the Settings
Fall due to incorrect or unfamiliar settings
▶ Only adapt the settings to the patient gradually.
▶ Explain the effects of the adjustments on the use of the prosthesis to the patient.

Setting the hip extensor
▶ Set the hip extensor according to Figure 9 on page 10 in such a way that hip extension is always achieved while walking, while ensuring it does not knock against the stop too hard ( increasing spring pre-tensioning, reducing spring pre-tensioning).

Fine-tuning the settings
► The various settings of the prosthesis cannot be adjusted entirely independently of each other. If the settings cannot be fully adjusted to the comfort needs of the patient, the settings should be established primarily based on safety aspects.
► Adapt the settings of the prosthetic components to the patient by means of fine-tuning and exercises.
► Check the adjustment of the prosthesis settings during normal consultations and as part of the annual safety inspections. Advise the patient to have the prosthesis inspected by qualified personnel if changes in function occur.

7.5 Attaching the cosmetic cover

⚠ CAUTION
Use of highly hygroscopic particles (grease-absorbent sub stances such as talcum)
Risk of injury, damage to the product due to lack of lubrication

► Do not allow the product to come into contact with highly hygroscopic particles.
► To reduce friction and to eliminate noise, apply 519L5 Silicone Spray directly onto the contact surfaces of the cosmetic foam cover.
► After affixing the cosmetic elements, verify proper functioning of the prosthesis.

7.6 Finishing the prosthesis

▶ CAUTION! To avoid product damage and the risk of falling, finish the prosthesis by replacing set screws that are too short or too long, and by tightening all screw connections. In doing so, note the instructions for use for all prosthesis components regarding torque values and thread lock.

Securing the abduction/adduction position ( 10 on page 11) Secure the abduction/adduction position as shown in the illustration:

→ (1) : Mark the position of the prosthetic hip joint
→ (2) : Use the 7Z68 drilling template
→ (3) : Bore through
→ (4) : Tighten the set screw

8 Use

8.1 Information for use

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.).

8.2 Cleaning

⚠ CAUTION
Use of unsuitable cleaning agents or disinfectants
Impairment of functionality and damage due to incorrect cleaning agents or disinfectants

► Clean the product only according to the instructions given in this section.
► For the prosthesis, observe the cleaning instructions for all prosthetic components.

Cleaning light soiling
1) Clean the product with a damp, soft cloth.
2) Dry the product with a soft cloth.
3) Allow to air dry in order to remove residual moisture.

Cleaning heavier soiling

Required materials: cleaning cloth, 634A58 isopropyl alcohol, soft cloth

► NOTICE! Verify material compatibility. Do not remove lubricant from bearing points.
► Clean the product with a cleaning cloth and isopropyl alcohol.
► Dry the product with a cloth.
Cleaning with Disinfectants

Required materials: colourless, alcohol-free disinfectant (verify material compatibility!), soft cloth
► Disinfect the product with the disinfectant.
► Dry the product with a cloth.
► Allow to air dry in order to remove residual moisture.

9 Maintenance

⚠CAUTION
Failure to follow the maintenance instructions Risk of injuries due to changes in or loss of functionality and dam age to the product

► Observe the following maintenance instructions.
► NOTICE! Repair work must be performed exclusively by the manufacturer’s technical service.
► Arrange regular maintenance intervals with the patient depending on the level of use.
► Following an individual period for the patient to get accustomed to the prosthesis, check the settings of the prosthetic joint and adapt them to the patient’s requirements again as needed.
► The prosthetic components should be inspected after the first 30 days of use.
► Inspect the entire prosthesis for wear during normal consultations.
► Perform a safety inspection every 3 months.
► As part of the safety inspections, inspect the prosthetic joint 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.
► In case of changes in prosthesis function or relevant patient changes (such as the activity level, body weight, body height), perform unscheduled inspections and implement measures according to the situation.

Lubrication
Figure 11 on page 12 shows which lubricants to use.
▶ Use lubricants on the product sparingly.

10 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.

11 Legal information

11.1 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.

11.2 CE conformity

The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of conformity can be down loaded from the manufacturer’s website.

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

References

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