ottobock 7E10 Helix3D Hips Right Joint Instructions

**Quality for life

7 E10 Helix3D**

System Components at a Glance

Scope of delivery of the Helix 3D Hip Joint|

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Adapter|
Knee Joint|
Tube Adapter|
Prosthetic Foot|

Reference determination tool

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Cosmetic Foam Cover

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Selection Tool

| In dependence of the mobility grade and re­ quirements of the pros­ thesis wearer we offer a corresponding fit­
ting package that can be composed of the system components shown on the left.

INFORMATION
Date of last update: 2021­10­19

• 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 in connection with the product, in particular, a worsening of the state of health, to the manufacturer and to the relevant authority in your country
• Please keep this document for your records

Explanation of symbols
WARNING Warnings regarding possible risks of severe accident or injury.
CAUTION Warnings regarding possible risks of accident or injury.
NOTICE Warnings regarding possible technical damage.
INFORMATION Additional information on the fitting/use.
Recommended accessories and materials for orthopedic technicians:

Important information about the Helix 3D Hip Joint System

INFORMATION
Before using the Helix 3D
Hip Joint System, please read these Instructions for Use carefully and pay special at­ tention to the safety information!
The prosthesis wearer must be taught how to handle, care for and operate his/her prosthesis properly. Please see the following Sections:
1.3 Conditions of Use,
1.5 Safety Instructions,
5.1 Technical Information
5.3 Legal information
1.1 Medical purpose
The Helix 3D Hip Joint System is to be used exclusively for the endoprosthetic fitting of patients with hip amputations such as intertrochanteric amputation, hip disarticulation or hemipelvectomy.
1.2 Field of application
The Helix 3D Hip Joint can be used by active prosthesis wearers as well as by prosthesis wearers who require a high degree of safety. Thanks to its hydraulic stance phase and swing phase control it offers functional safety and dynamic comfort.
Field of the application according to the Ottobock MOBIS® Mobility System:
Recommended for mobility grades 2 and 3 (restricted outdoor walker, unrestricted outdoor walker).
Approved for a body weight of up to 100 kg/220 lbs.

1.3 Combination possibilities
CAUTION
Failure to observe the manufacturer requirements regarding combination possibilities. Injuries, malfunc­ tions or product damage due to an unallowable combination 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 field of application.
• Contact the manufacturer with questions.

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.

Recommended combinations

Prosthetic knee joints| Kenevo 3C60, C­Leg 3C98­3, Genium 3B1, 3B1­2, 3B1­3, Ge­ nium X3 3B5­X3, 3B5­2, 3B5­3
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Unallowable combinations

Prosthetic knee joints| Kenevo 3C60=ST, C­Leg 3C88­3, Genium 3B1=ST, 3B1­2=ST, 3B1­3=ST, Genium X3 3B5­X3=ST, 3B5­2=ST, 3B5­3=ST
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1.4 Conditions of use
INFORMATION
Advise your patients of the information in this section.
CAUTION
Risk of injury when using the product on several patients. The Helix 3D Hip Joint System is a medical product, which is designed exclusively for fitting on one patient. Use of the product by a further person is prohibited. The Helix 3D Hip Joint System has been designed for everyday life activities. It is not suitable for sports activities and especially not for activities such as jogging, jumping, free climbing, parachute jumping, paragliding etc. For the necessary environmental conditions, please see Section 5.2 “Technical information”. Careful handling of the prosthesis and its components not only increases their service life but, above all, ensures the safety of the prosthesis wearer!
1.5 Qualification of the prosthetist
The fitting with a Helix 3D Hip Joint System may only be carried out by prosthetists who have been authorized by Ottobock with a corresponding certification.
1.6 Safety instructions
CAUTION
Risk of injury in case of failure to follow the safety instructions. Failure to follow the safety instructions men­ tioned below can lead to faulty control or malfunction of the Helix 3D  Hip Joint System and result in risk of injuries for the prosthesis wearer. Therefore, also advise the prosthesis wearer of the following rules.
1.6.1 General safety instructions
CAUTION
The danger is caused by alignment and adjustment errors. During alignment and adjustment of the prosthesis, errors can occur resulting in malfunction of the joint up to loss of function due to structural failure. This can cause the patient to fall.
CAUTION
Participation in an Ottobock certification course for the Helix 3D Hip Joint System is obligatory before the first fit­ ting. Additional product training courses may become necessary to qualify for fitting product updates.
CAUTION
Risk of injury caused by manipulations on system components. Any changes or modifications you make to system components on your own initiative can lead to malfunction of the joint up to loss of function due to struc­ tural failure. This can cause the patient to fall.

• Any changes or modifications to the system may limit its use.
• The joint may only be opened and repaired by authorized Ottobock technicians. No adjustments or modifica­ tions on the Helix 3D Hip Joint except those described in this manual are permitted.

CAUTION
Malfunctions are caused by using inappropriate prosthetic components. The Helix 3D hip joint system may only be used with the C­Leg, the Genium and the prosthetic feet intended for use with them.
CAUTION
Component failure is caused by exceeding the safe service life. This component has been tested according to ISO 15032 standard for two million load cycles. Depending on the amputee’s activity level, this corresponds to a usage duration of 2 to 3 years for a hip disarticulation or an amputee with a hemipelvectomy. Using the component beyond this period can result in component failure and cause the amputee to fall. In general, we recommend annual safety checks.
1.6.2 Instructions for prosthesis wearers
INFORMATION
The prosthesis wearer must be advised of the appropriate handling of the Helix 3D Hip Joint as well as of the Instructions for Prosthesis Wearers mentioned below.
WARNING Risk of an accident when driving a motor vehicle. The ability of prosthesis users to drive a vehicle is determined on a case-by-case basis. Criteria include the type of fitting (amputation level, unilateral or bilateral, residual limb conditions, design of the prosthesis) and the amputee’s individual abilities.
All persons are required to observe their country’s national and state driving laws when operating motor vehi­ cles. For insurance purposes, drivers should have their driving ability examined and approved by an authorized test center.
For maximum safety and convenience, Ottobock recommends that, at the very least, a specialist evaluate the need for any adaptations to the car (such as by installing a steering fork, or automatic shift). Risk­free driving should be ensured even when the prosthesis is not functioning.
CAUTION
Risk of injury as a result of excessive strain. The Ottobock prosthetic components described here have been developed for activities of daily living and must not be used for unusual activities such as extreme sports (free climbing, paragliding etc.).
Careful handling of the prosthesis and its components not only increases their service life but, above all, ensures the patient’s safety!
Should prosthetic components be subjected to unusual stresses (such as a fall), immediately contact your pros­ theist and have the components inspected for any damage? If necessary, the responsible prosthetist will pass the prosthesis on to the Ottobock Service.
CAUTION Risk of injury when continuing to use the product after noticeable functional changes have occurred. To re­ duce the risk for the prosthesis wearer, the Helix 3D Hip Joint System must no longer be used when noticeable functional changes occur. Noticeable functional changes may include poor response, incomplete extension, diminished swing phase control or stance phase stability, abnormal noises etc.  Should such a change occur, the hip joint must be inspected by a prosthetist and possibly be returned to Ot­-tobock for repair.
CAUTION Risk of falling when climbing stairs. On stairs, the prosthesis wearer always has to use the handrail.
NOTICE Risk of damage caused by overheating of the hydraulic unit. Extended, continuous use (e.g. lengthy downhill walks) can lead to overheating of the hydraulic element/ hydraulic damper involving liquid leakage. If activities are continued, the Helix 3D can become damaged in extreme cases. The joint must then be sent to an authorized Ottobock Service for inspection.
1.6.3 Instructions on the handling of the prosthesis
NOTICE Damage caused by corrosion. Prosthetic components must not be exposed to corrosive elements such as fresh water, salt water and acids.
Using this medical product in such environmental conditions will render all claims against Otto Bock HealthCare null and void.
NOTICE Damage due to incorrect environmental conditions. Prosthetic components must not be subjected to intense smoke, dust, vibrations, shocks or high temperatures. Do not allow solid particles or liquids (such as sweat) to get into the components. Failure to follow these instructions can lead to malfunctioning and damage to the prosthesis.

• Avoid areas with extremely high humidity and temperatures.
• Should the joint come into contact with liquid, remove the cosmetic foam cover and let the components dry.
• Should the joint come into contact with salt water, immediately clean it with a cloth moistened with fresh water and let it dry. Contact your prosthetist to have the hip joint sent to an authorized Ottobock Service Centre for inspection.

NOTICE Damage caused by improper cleaning agents. Do not use any aggressive cleaning agents since they could cause damage to bearings, seals and plastic parts.

Description and function

2.1 Design
The patented Helix 3D Hip Joint is the first commercially available hip joint with hydraulic stance phase and swing phase control. Its design features enable the prosthesis wearer to achieve a harmonious and smooth gait pattern. The following particularities characterize the hip joint:

• Spatial movement of the hip: The patented, multi­axis joint structure effectuates spatial movement of the hip. In addition to usual flexion and extension, this spatial movement is a combination of abduction and adduction as well as inward and outward rotation imitating natural movement. Therefore, the Helix 3D Hip Joint versions 7E10=L for left­side amputees and 7E10=R for right­side amputees are available. In addition, the multi­axis joint structure results in a greater reduction of the leg length during the swing phase and thus facilitates walking with the prosthesis.
• Hydraulically controlled extension and flexion: An innovative hydraulic unit controls the resistance of the hip joint during each phase of gait. During the stance phase, it allows for dampened, controlled heel strike with a significantly reduced backward tilt of the pelvis (hyperlordosis) as well as harmonious hip joint extension. The hydraulic unit also controls the stride length during the swing phase. It can be adjusted to the individual require­ ments of the prosthesis wearer.
• Support of swing phase initiation: During the stance phase, integrated expansion springs store mechanical energy. This energy is used to initiate the swing phase in order to compensate to some degree for the missing hip flexors. As a result, less energy is required for walking.
• Optimal sitting characteristics: Since the Helix 3D  Hip Joint has a low structural height when installed, “pelvic obliquity” in the sitting position can be reduced to a minimum. Moreover, the flexion angle of the Helix 3D Hip Joint is very large enabling comfortable sitting.

2.2 Fitting packages
The Helix 3D Hip Joint’s functions are specially adapted to the characteristics of selected Ottobock components. Proper function of the Helix 3D Hip Joint during the liability period can only be guaranteed, if it is used in combina­ tion with the appropriate products (see “System Components at a Glance”, p. 2). Please select the corresponding fitting package according to the mobility grade and requirements of the prosthe­ sis wearer, as explained during the certification workshop.

Alignment, adjustment and assembly

INFORMATION
Correct alignment is crucial for the optimal function of the prosthesis!
For this reason, a test socket is used for the works described in sections 3 and 4 (positioning of the lamination
plate, alignment, dynamic trial fitting). The manufacturing technologies required for these works (including those required for the definitive pelvic socket) are taught during the certification workshop.
INFORMATION
For the alignment of the prosthesis described below, please proceed in two steps: First make the bench alignment using an alignment tool such as 743L200 L.A.S.A.R. Assembly.
For subsequent optimization of the static alignment, please use 743L100 L.A.S.A.R. Posture.
Use 2Z11=KIT
INFORMATION
The connection area of the prosthetic knee joint can be protected against scratches with the protective film of the 2Z11=KIT during alignment in the workshop and testing in the trial fitting area.

• Use the protective film as illustrated in the accompanying document for the 2Z11=KIT.
• Remove the protective film before the patient leaves the fitting area.

INFORMATION
For use of the C­Leg: Before adjusting the gait parameters on the Helix 3D hip joint also observe the C­Leg Instructions for Use (647H215) and the C­Soft Instruc­ options for Use (647G268). For use of the Genium: Before adjusting the gait parameters on the Helix  3D hip joint also observe the Genium Instructions for Use (647G573) and the X­Soft operation description contained therein. When entering patient data in the ‘Alignment’ menu there, ensure that hip disarticulation is selected under ‘Residual limb conditions.
3.1 Practical determination of the alignment reference on the pelvic socket
For sagittal placement of the pelvic socket in the prosthesis system, determina­ tion of an alignment reference in a neutral pelvic socket position determined under load is required. In this neutral position (Fig. C) the patient does not feel anteriorly or posteriorly tilting moments in the sagittal plane, and the pelvic tilt position is as physiological as possible. Proceed as follows:

1. Adjust the height of the casting table to the ischial tuberosity to a ground distance of the patient.

2.  Place the patient with optimally applied pelvic socket without prosthetic compo­ nets with the prosthesis side on the casting table observing the following criteria:
   • Bring the middle of the contralateral foot and the middle of the pelvic socket on the prosthesis side sagittal in a – p direction on one level.
   • Optimally adjust the pelvic rotation and pelvic tilt.

3. Lower the plate of the casting table by the height of the reference determination tool (743A29) (approx. 4.5 cm).

4. Position the reference determination tool between the bottom of the pelvic socket and casting table according to the following criteria:

Frontal plane:

• Position the reference determination tool (743A29) approximately 5 – 6 cm laterally to the medial socket trim lines.

Sagittal plane:

• First, place the reference determination tool (743A29) in the maximal anterior position (the patient will feel a backward tilt of the pelvis, Fig. A).
• Then, place the cone tip in the maximal posterior position (patient will feel for­ ward tilt of the pelvis, Fig. B).
• Now shift the reference determination tool (743A29) sagittally in small increments between the maximal positions. Have any new position described by the test subject as a forward or backward tilt of the pelvis or maybe as a neutral position (see above; Fig. C).

5. Marking of the determined neutral position:

• Mark a vertical pelvic socket reference line sagittally on the pelvic socket running through the center of the reference determination tool (743A29) (also see laser markings; Fig. C).
• Mark the level of the contralateral greater trochanter on this line.In the following, these markings will serve as alignment reference (partial mass centre of gravity).

3.2 Positioning of the lamination plate
INFORMATION
During plaster cast taking, please make sure to apply the front casting block with an external rotation position of 5°.
The bottom side of the lamination plate must not be shortened or bent.
If required, the front side of the lamination plate can be reduced in length to some degree and the corners be rounded off. However, sufficient material must be left for later assembly of the connection system. Excessive reduction of the front side of the lamination plate can have negative effects on the later laminate connection to the pelvic socket. For correct positioning of the pelvic socket/lamination plate, please proceed as follows:

1. Preparation: First bring the bottom side of the lamination plate in a horizontal position (sagittally and frontally).
2. Positioning in the sagittal plane (Fig. 1): Position the pelvic socket in accordance with the determined pelvic socket reference line as far anteriorly over the lamination plate as possible. Pay attention to that the pelvic socket reference line is perpendicular to the horizontally positioned bottom side of the lamination plate.
3. Positioning in the frontal plane (Fig. 2): Position the pelvic socket in accordance with the determined pelvic tilt. Transfer half of the mediolateral measurement y between the center of the body and the contralateral outer side to the pelvic socket side (y/2) and make a vertical mark. The middle of the lamination plate’s front side should coincide with this vertical mark.
4. Positioning in the transversal plane: Position the pelvic socket in the walking direction in accordance with the determined pelvic rotation position. Pay attention to that the front side of the lamination plate is applied with an external rotation position of about 5°.

3.2.1 Important information on the completion of a Helix 3D test prosthesis
Maximal abduction / adduction

1. Use only the bore holes in the lamination plate marked in Figure 1 below to screw the lamination plate (7Z53) to the pelvic socket in the frontal plane.
   This will allow maximal abduction/adduction adjustment of the hip joint, if necessary (Fig. 2).

2. On the bottom side of the lamination plate, all bore holes can be used for the screw connection to the pelvic socket.

Maximal internal/external rotation – use of the 4G576 Spacer Washer
INFORMATION
As described in Section 3.2 (positioning of the lamination plate) of the Helix 3D hip joint instruction manual, ensure that you insert the plaster wedges rotated outwards 5° when plastering the pelvic socket. For the test fitting period, use the spacer provided as shown in the figures below. In this way, maximal internal and external rotation of the hip joint can be set/used, without the posterior linkage bar contacting the lamination plate.
INFORMATION
The 4G576 Spacer Washer is intended solely for use during the trial fitting period. When fabricating the defini­ tive pelvic socket, make sure that the lamination plate is attached with sufficient external rotation and that the pelvic socket has a laminate thickness of at least 2.5 mm. If the posterior linkage bar of the hip joint contacts the pelvic socket in spite of this, you can grind the laminate at this point.![ottobock 7E10 Helix3D Hips Right Joint

• fig 15](https://manuals.plus/wp-content/uploads/2022/08/ottobock-7E10 -Helix3D-Hips-Right-Joint-fig-15.png)

3.3 Adjustment possibilities Prior to fixing the Helix  3D Hip Joint to the pelvic socket and making the adjustment proximal to the hip joint, the upper section cap must be removed (Fig. 1). INFORMATION
Fix the Helix 3D Hip Joint at the lamination plate solely with the accessories which are included in the delivery!
INFORMATION
To fasten the 7E10 to the pelvic socket do not use the spherical washers used with the 7E7 hip joint under the 501F9=* flat head Torx-type screws.
To adjust, please proceed as follows:

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1. Abduction and adduction (Fig. 2): To adjust abduction or adduction, loosen the lower and upper screw and turn the hip joint around the lower screw. Torque: 25 Nm using Torx Bit TX40 (see also page 43).
2. Rotation (Fig. 3): To adjust inward and outward rotation, loosen the lower, middle and upper screw. Before­ hand, mark the abduction/adduction with a pencil. Torque of the middle screw: 2 Nm. Use a 709S10=2.5 Al­ len wrench (see also page 43).
3. Distal hip joint adjustment (Fig. 4/5): The lower pyramid adapter allows for tilt of the knee joint in M­L and A­P direction. This allows you to properly arrange the knee joint in the prosthesis.

3.4 Bench alignment with alignment tool
CAUTION
Danger as a result of incorrect alignment. Errors during the alignment of the prosthesis can lead to malfunc­ tion of the joint up to loss of function due to structural failure. This can cause the patient to fall. During bench alignment, it is essential to make sure that the hip joint is fully extended! Preparing the hip joint for bench alignment:
To facilitate alignment in the L.A.S.A.R. Assembly, please remove the integrated expansion springs as described in Section 3.8.
Fix the hip joint in full extension using the enclosed cable tie. Position the cable tie approximately at the level where the lower section ends (Fig. 2).
Bench alignment with alignment tool The alignment step order corresponds to the numbers in the alignment scheme.
First make the bench alignment of the prosthesis witha  fully extended hip joint (see page 13) using an alignment tool such as 743L200 L.A.S.A.R. Assembly. Please proceed as follows:

1. Position the middle of the foot approx. 30 mm anterior to the alignment reference line. This applies to all recommended prosthetic feet, independently of alignment recommendations in previous instructions for use!

2. Add + 5 mm to the required shoe heel height and set the correct outward rotation of the foot.

3. Clamp the knee joint with the mounted tube adapter into the alignment tool. Place the alignment reference point (=knee axis) approx. 0 – 5 mm anterior to the alignment reference line. Consider the knee-floor distance and outward rotation of the knee (approx. 5° are provided for by the adapter insert clamp in the L.A.S.A.R. Assembly). Recommended positioning of the alignment reference point: 20 mm above the contralateral medial tibial plateau. Connect foot and modular knee joint using a tube adapter. To do so, tilt the joint in the correct position and set the required tube length.

4. The Helix 3D hip joint and the knee joint are connected by means of a tube clamp adapter and a tube. The ap­propriate clamp adapter can be selected according to the 4×189=D/GB Selection Disk for the Helix 3D Hip Joint System.
   NOTICE
   Damage caused by neglected cleaning/deburring. Prior to final assembly (i.e. prior to inserting the tube adapter into the tube clamp adapter), the inside of the tube clamp adapter and the outside of the tube adapter must be cleaned with 634A3 (Acetone)!
   Prior to assembly, make sure that the cut tube is completely free of burrs.

5. Readjust the clamp adapters to set the determined pelvic socket reference line 35 mm anterior and parallel to the alignment reference line. Pay attention to that the hip joint remains in the maximal extension position. In the frontal plane, the alignment reference line should run through the middle of the two attachment screws of the lamination plate.

6. In the transversal and frontal plane, make sure that the upper posterior hip joint axis is parallel to the knee joint axis.
   For use of the C­Leg: Carry out the basic settings on the C­Leg without the patient (zeroing, setting maximum load and stance phase damping to maximum values; please also see the 647G268 Instructions for Use). These are only safety settings for the initial standing trials and the first steps to the L.A.S.A.R. Posture with the patient.
   For use of the Genium: The Genium should also be locked for the first steps to the L.A.S.A.R. Posture and dur­ ing first joint adjustments. The prosthetist should accomplish this by switching to ‘Static’ (so-called static alignment measurement) under the ‘Alignment’ tab. The joint is then locked.

3.5 Static alignment optimisation (with L.A.S.A.R. Posture) Preparing the prosthesis for alignment optimization:

• Make sure that the Helix 3D Hip Joint has been adjusted to the factory settings (also refer to Section 3.6).
• Remove the cable tie.
• Reintegrate the PU springs. Proceed in the reverse order as described in Section 3.8!
• Tighten the screws with the torques as defined in Section 3.7.
• Verify the length of the prosthesis on the patient.

Alignment control and optimization of the prosthesis under load should be done using the 743L100 L.A.S.A.R. Posture.

1. Adapt the alignment by only adjusting the plantar flexion.
2. The load line should run approx. 30 mm anterior to the pivot point of the knee joint.
   The prosthesis side should be sufficiently loaded (> 35% of the body weight). The following values can be used to check the alignment: The load line should run approx. 50 mm anterior to the ankle adapter screw (dependent on the type and size of the prosthetic foot) as well as approx. 0 to ±10 mm through the pelvic socket reference line.
   After completion of the alignment, reassemble the upper section cap of the Helix 3D Hip Joint.

3.6 Dynamic trial fitting

INFORMATION
Please make sure you are thoroughly familiar with the adjustment possibilities and their effects! Only then you will be able to optimally adjust the prosthesis to the requirements of the prosthesis wearer.
INFORMATION
For use of the C­Leg: Always also observe the C­Leg knee joint Instructions for Use (647H215) and the C­Soft Instructions for Use (647G268) before adjusting the gait parameters on the Helix 3D  hip joint.For use of the Genium: Always also observe the Genium knee joint Instructions for Use (647G573) and the description of use of the X­Soft contained therein before adjusting the gait parameters on the Helix 3D hip joint.
3.6.1 Explanation of the adjustment possibilities

Parameter| The hip joint allows to set a certain stride length within which it flexes freely i. e. with­ out resistance.| The free swing range is fol­ lowed by a significant increase in resistance to limit the stride.| The stance phase resistance allows comfortable extension of the prosthesis.
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Factory setting| Low| High| Low
Adjustment feature| Lower adjustment lever is set to left position.| Left adjustment screw of the hydraulic unit is fully turned to the right.| Right adjustment screw of the hydraulic unit is fully turned to the left.

INFORMATION During adjustment, the free swing range (FSW) and swing phase resistance (SW) have an effect on one an­ other. A correction of the free swing range may therefore become necessary.
3.6.2 Gait parameter adjustment
CAUTION
Risk of falling during trial walking. For safety reasons, let the prosthesis wearer make the first steps always within parallel bars! Otherwise there is the risk of falling.
CAUTION
Risk of falling caused by uncontrolled knee joint flexion. The expansion springs integrated in the Helix 3D Hip Joint cause the hip joint to flex after standing up or lifting the prosthesis. This can result in uncontrollable knee joint flexion during the subsequent heel strike. Instruct the prosthesis wearer about these characteristics of the hip joint!
CAUTION
Damage caused by inappropriate adjustment tools. Using inappropriate adjustment tools can cause damage to the hydraulic unit. Only the adjustment wrench 710H10=2X3 is to be used for adjustment.
INFORMATION
For use of the C­Leg: Always also observe the C­Leg knee joint Instructions for Use (647H215) and the C­Soft Instructions for Use (647G268) before adjusting the gait parameters on the Helix 3D hip joint.
For use of the Genium: Always also observe the Genium knee joint Instructions for Use (647G573) and the description of use of the X­Soft contained therein before adjusting the gait parameters on the Helix 3D hip joint.
First check the factory settings as described in section 3.6.1 To adjust please proceed as follows:

1. Gradually increase the free swing range (stride length) until the stride length on the prosthesis side approximately corresponds to that of the sound side. The set stride length should not exceed the stride length of the sound side.
2. Reduce the high factory setting of the swing phase resistance so that the flexion resistance is clearly noticeable but still comfortable. This will make safe heel strike possible.  Please note: Since the two adjustment parameters have an effect on one another, a correction of the free swing range may become necessary. Now make C­Leg® adjustments.
3. Notice: Increasing the stance phase resistance can cause stance phase flexion of the knee joint. If the stance phase resistance setting is too high, uncon­ trolled knee joint flexion can result. Increase the stance phase resistance step by step and give the prosthesis wearer the opportunity to get accustomed to this resistance. Stance phase resistance adjustment should be made over a longer period. With optimally adjusted resistance, the prosthesis wearer will slowly sink into the Helix 3D
   Hip Joint in the stance phase and reach maximal extension of the hip joint just before initiation of the swing phase.

3.6.3 Possible problem solutions
If the knee joint does not extend during the stance phase after stance phase flexion when used with the Helix 3D  hip joint, this may be due to a number of different reason s.Therefore, please check the possible causes and, if applicable, make the specified adaptations to achieve knee joint extension during the stance phase:
C-Leg / Genium: no extension during the stance phase

the stance phase resistance (Section 3.6.2).
The stride length, which results from the free swing range and the swing phase resistance, is set too high.| Increase the swing phase resistance and/or reduce the free swing range (Section 3.6.2).
The prosthetic alignment is not optimal.| Control and optimization of the sagittal prosthetic alignment under load (section 3.4).
Stance phase damping of the knee joint is too low.| The stance phase damping settings of the knee joint should be optimized for sitting down and for step­over­step climb­ ing and descending of stairs and ramps.

If the C­Leg®, in addition, does not switch to the swing phase mode at the end of the stance phase when using the Helix 3D Hip Joint, this can have the following causes:
C-Leg® does not switch to the swing phase

load during walking using C­Soft and correct, if necessary
C­Soft Instructions for Use: 647G268).

If the Helix 3D Hip Joint does not go into extension at heel strike, this can have several causes. Therefore, please check the following possible causes and, if applicable, make the specified adaptations to achieve the extension of the Helix 3D Hip Joint at heel strike:
Helix 3D : no extension at heel strike

the stance phase resistance (Section 3.6.2).
The stride length, which results from the free swing range and the swing phase resistance, is set too high.| Increase the swing phase resistance and/or reduce the free swing range (Section 3.6.2).
The prosthetic alignment is not optimal.| Control and optimization of the sagittal prosthetic alignment under load (section 3.4).

INFORMATION
Stance phase resistance is a new aspect in the prosthetic fitting after amputations in the pelvic area. Therefore, please make the adjustment very carefully and permanently check whether the resistance can be increased further! It is important for the prosthesis wearer that he can put weight on the prosthesis as long as possible during the stance phase. The stance phase on the moving hip joint is possible because of the high resistance and should be considered the goal of the walking training, even if the prosthesis wearer might feel uncomfortable in the beginning. Please take the time to understand this important procedure and to explain and practice the procedure with the pros­ thesis wearer. Only then the prosthesis wearer will be able to fully benefit from the advantages of this product.
3.7 Reinforcing the Prosthetic Socket
INFORMATION
The following reinforcing instructions only refer to the connection and stability of the lamination plate in the hip prosthesis socket.
For patients with a body weight near the allowable top limit and with expected high mobility, it is recommended to apply at least 2 extra layers of carbon fibre mesh and 2 extra layers of nylon stockinette.
Recommended materials:
Nylon Stockinette, 616G12 Carbon Fibre Mesh, 616G4 Fibreglass Mat, 699B1 Fibreglass Roving, 636K8 Plasta Tape

1. Pull 2 layers of nylon stockinette over the plaster positive.
   à The 1st and 2nd layers of nylon stockinette are applied.

2. Apply carbon fibre mesh in the area of the sitting surface and lamination plate.

3. Apply fiberglass mat in the area of the sitting surface and lamination plate.

4. Apply carbon fiber mesh offset at 45° to the first layer of carbon fiber mesh in the area of the sitting surface and lamination plate.

5. Pull 2 layers of nylon stockinette over the plaster positive.
   à The 3rd and 4th layers of nylon stockinette are applied.

6. Pull 2 layers of nylon stockinette over the plaster positive.
   à The 5th and 6th layers of nylon stockinette are applied.

7. Pull fiberglass roving through the holes in the cleaned lamination plate.

8. Close the threaded holes in the lamination plate with plastic tape.

9. Position the lamination plate on the plaster positive.

10. Pull 2 layers of nylon stockinette over the plaster positive.
    à The 7th and 8th layers of nylon stockinette are applied.

11. Apply carbon fibre mesh in the area of the sitting surface and lamination plate.

12. Apply carbon fiber mesh offset at 45° to the first layer of carbon fibre mesh in the area of the sitting surface and lamination plate.

13. Pull 2 layers of nylon stockinette over the plaster positive.
    à The 9th and 10th layers of nylon stockinette are applied.

14. Apply carbon fiber mesh in the area of the sitting surface and lamination plate.

15. Apply carbon fiber mesh offset at 45° to the first layer of carbon fibre mesh in the area of the sitting surface and lamination plate.

16. Pull 2 layers of nylon stockinette over the plaster positive.
    à The 11th and 12th layers of nylon stockinette are applied.

3.8 Finishing the prosthesis
The 3S27=L/R44 Foam Cover can be used for finishing the pelvic socket prosthesis. Allow a 60 mm “compres­ sion allowance” to minimise the protective foam cover’s effect on knee function. When determining the proper cover length, increase the linear thigh dimension by 30 mm and the linear shin dimension by the same amount. Use 710D4 Torque Wrench to finish the prosthesis and secure all set screws with 636K13 Loctite. Please observe the following torques:

(Wrench/Bit TX 40)
Small cap screw of lamination adapter| 2 Nm
Set screws of rotation adapter 4R57| 10 Nm / Torque above the rotation adapter
All other set screws| 15 Nm

Finally, verify once again that all adjustments are optimal by having the prosthesis wearer walk with the finished prosthesis. If necessary, readjust the prosthesis to compensate for the influences by the foam cover.
3.9 Maintenance
Replacing the expansion springs
To support the swing phase (flexion), the joint contains tension springs on the left and right (order no.: 4G430, red). These springs store energy during the extension of the Helix 3D  Hip Joint in the stance phase and return the energy at the beginning of flexion. This results in significantly faster initiation of hip flexion and larger ground clearance
during the swing phase. Two additional normal tension springs (order no.: 4G430, red) and two stronger tension springs (order no.: 4G430=2, grey) are included.
Worn or defective expansion springs can be replaced as follows:

1. First open the front cap.

2. Then replace the defective expansion springs with new ones.
   INFORMATION
   To remove the expansion springs, use a slotted screwdriver without sharp edges! Before installing the 4G430 or 4G430=2 expansion springs, the eyelets of the expansion spring must be greased throughly with 633F30 special grease (Fig. 1).

3. Close the cap and insert the attachment pins in the lower section.

3.10 Maintenance instructions
Please make your patients aware of the following safety instructions:
CAUTION
Risk of injury as a result of excessive strain. Depending on the environment and usage conditions, the func­ tionality of the hip joint may be impaired. To reduce the risk for the patient, the hip joint must not be used after noticeable functional changes have occurred.
Noticeable functional changes may include poor response, incomplete extension, diminished stance phase sta­ ability, deteriorating swing phase behavior, abnormal noises, etc.
Measure: Have the prosthesis inspected by a prosthetist.
NOTICE
Risk of damage caused by improper cleaning agents. The use of aggressive cleaning agents must be avoided.
They may cause damage to bearings, seals and plastic parts.
Do not disassemble the joint! Please send the joint to Ottobock if any problems arise.
INFORMATION
This component has been tested according to ISO 15032 standard for two million load cycles. Depending on the amputee’s activity level, this corresponds to a usage duration of 2 to 3 years for a hip disarticulation or an amputee with a hemipelvectomy.
In general, we recommend annual safety checks.
INFORMATION
Due to the use of control functions which are performed hydraulically, movement noises may result when exopros­ thetic hip joints are used. This kind of noise is normal and inevitable. It generally does not cause any problems. If the movement noises increase noticeably over the life cycle of the hip joint, the joint should be inspected im­mediately by a prosthetist.
The manufacturer recommends having the Helix 3D Hip Joint inspected and any adjustments required made after it has been used for several weeks. After a certain adaptation phase, prosthesis wearers usually appreciate a slightly higher extension resistance in the stance phase. Please check the hip joint for wear and proper function once a year and make adjustments, if necessary. Special attention should be paid to movement resistance, brake tolerance changes and abnormal noises. Full flexion and extension must be guaranteed. Do not disassemble the joint. Please send the complete joint to Ottobock for repair in case of problems.

Gait training

Prosthesis wearers can optimally benefit from the Helix 3D Hip Joint’s features only if they are properly instructed and trained in walking. The following aspects are especially important for the gait training:

1. The prosthesis wearer walks with the hip joint flexed at heel strike; during the stance phase, the hip joint is then extended controlled by resistance.
   Unlike with conventional hip joints, the prosthesis wearer does not have to perform quick backward tilt of the pel­ vis. Hip joint extension can be controlled by resistance during the entire stance phase thereby reducing abrupt backward tilt of the pelvis upon weight bearing. Especially to experienced prosthesis wearers this is unfamiliar in the beginning and has to be practiced consciously.

2. The expansion springs facilitate the initiation of the swing phase. Pelvic tilt can therefore be reduced. Inform the prosthesis wearers that they have to perform only significantly reduced pelvic tilt to swing the prosthe­ sis forward because the Helix 3D Hip Joint is brought into flexion by the expansion springs. The prosthesis wearer must learn how far the prosthetic foot swings forward when the prosthesis is lifted by the expansion springs. This is very important especially for waking downstairs, in order to be able to precisely place the foot.

Additional information

5.1 Technical information

5.2 Disposal
In some jurisdictions, it is not permissible to dispose of the product with unsorted household waste. Improper dis­ postal can be harmful to health and the environment. Observe the information provided by the responsible autho­ cities in your country regarding a return, collection, and disposal procedures.
5.3 Legal information
All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.
5.3.1 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 disregard of this document, particularly due to improper use or unauthorized modification of the product.
5.3.2 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.
5.3.3 Trademarks
All product names mentioned in this document are subject without restriction to the respective applicable trade­ mark laws and are the property of the respective owners.
All brands, trade names or company names may be registered trademarks and are the property of the respective owners.
Should trademarks used in this document fail to be explicitly identified as such, this does not justify the conclusion that the denotation in question is free of third­party rights.

……………………………..

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
© Ottobock · 647G387=all_INT-16-2110

Documents / Resources

| ottobock 7E10 Helix3D Hips Right Joint [pdf] Instructions
7E10, Helix3D Hips Right Joint, Hips Right Joint, Right Joint, 7E10, Helix3D Joint
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