ottobock 7E5 Modular Single Axis Hip Joint Instruction Manual

: June 4, 2024
: ottobock

ottobock 7E5 Modular Single Axis Hip Joint

ottobock 7E5 Modular Single Axis Hip Joint product

Hip Joint 7E5=L/R

ottobock 7E5 Modular Single Axis Hip Joint 1

7Z59 Thigh Tube consisting of 721 Thigh Tube
501T19-M4x10 Countersunk
Screw
Stoinl
(1.3) 7Z17 Double Hinge sisting of (1.3 a) 7Z25 Attachment Plate
(1.3 b) 7Z27 Insert Piece
(1.3 c) 7Z21-63 Axis
(1.3 d) 7221=70 Axis
(1.3 e) 7Z35 Lamination Anchor
(1.3 f) 507S23
Locking Rings
ST 722 Lamination Plate 501S41=M6x20
Countersunk Screw
7Z16 Adjustment Disk 724-84
Posterior Strut Housing
Lb2 Posterior strut 506AB=5×36 Cylinder Pin
513D18-4.7×55 Compression Spring 8 7Z40 Guide Pin
7Z7 Threaded Plate 10) 7Z8=L/R Extension
Stop Bumper on siting of 7Z30=L/R Stop Bumper
7Z9 Extension Stop
7Z13 Locking Hook
7Z12 Lock Axis
7Z11=L/R Coil Spring
72Z10 Lock Lever
1OY1 Finger Cover
50122=M6x35 Cap Screw
7Z14 Wire Bow with Past.
Roller (12) 501T19
M4x8 Countersunk Screws
Stain
501T19-M4X6 Countersunk
Screw
Stain.

7D5 Single Component Pack for 7E5=L/R

Consisting of 4 Lock Rings
Wire Bow with Plast
Roller 1 Stop Shel
4 Cap Screw
2 Guide Pins
1 Posterior Strut
Compl.

Hip Joint 7E4

7Z59 Thigh Tube consisting of 721
Thigh Tube (1.2) 501T19-M4x10 Countersunk Screw,
Stainl
7Z17 Double Hinge consisting of 7Z25 Attachment
- Plate 7Z27 Insert Piece
- 7Z21-63 Axis (1.3 d)
- 7Z21=70 Axis (1.3 e) 7Zz35
- Lamination Anchor 1.30 ST507S23 Lock Rings.
7Z2 Lamination Plate
501S41=M6x20 Countersunk Screws
7Z16 Adjustment Disk
7Z4=70 Posterior Strut Housing
7Z5=77 Posterior Strut
7Z38 Bumper
7Z18 Stop
Shell consisting of 7Z20
Stop Shell 50122
M6x25 Cap Screw 7Z14
Wire Bow with Plast
Roller Hip Extensor
619R4-50×10 Hip Extensor
501T19-M4x8 Countersunk Screws
619R4-50×8 Hip Extensor stainl
501S40-3,5×13 Oval Head Screws
501T19-M5X10 Countersunk Screw
Stainl 7Z32 Proxim
Extens.Assist Anchor 7239
Distal Extens
Assist Anchor
7237 Extension Stop

7D4 Single Component Pack for 7E consisting

4 Lock Rings 1 Distal Extens.
Assist Anchor 1
Wire Bow with Plast
Roller 1 Proxim
Extens.Assist Anchor
Extension Stop
Hip Extensor
Countersunk Screws
Posterior Strut
Comnl

INFORMATION

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 tor your records.

Explanation of warning symbols

CAUTION
Warnings regarding possible risks of accident or injury.

INFORMATION
Additional information on the fitting/use.

Indications for use and description

The Ottobock Modular Hip Joints 7E4/7E6=L/R are to be exclusively used for prosthetic fitting of the lower extremities. These two Modular Hip Joints are of the same design but differ from each other by the inclusion of a lock, or possibly, of an extension assist. The connection to the pelvic girdle is made with the Attachment Plate 7725, which is incorporated into the lamination resin.

Area of application

CAUTION

Reuse on another patient

Risk of injury due to loss of functionality as well as damoge to the product. Only use the product for a single patient.

Modular Hip Joint 7E5=L=R

Field of application according to the Ottobock Mobility System MOBIS. Recommendation for mobility degree 1 (indoor walkers) Approved for a patient with a weight of up to 100 kg. The joint is automatically secured in the extended position by the built-in lock. In order for the patient to sit down, the lock can be disengaged with the Lock Lever. The location of the Lock Lever 7210 depends on whether it is a left- or right hand version.

Modular Hip Joint 7E4

Field of application according to the Ottobock Mobility System MOBIS: Recommendation for mobility degrees 1 and 2 (indoor walkers and restricted outdoor walkers. Approved for a patient with a weight of up to 100 kg. Instead ofa lock, this Modular Hip Joint is provided with an Extension Assist with lateral elastic pull rings and an Extension Stop Shel. The Extension Assist limits the range of motion of the joint during walking and brings the prosthesis back into an extended position. The Ottobock MOBIS is not intended to be used as a guide to obtaining reimbursement for prosthetic components in the USA.

Environmental conditions

Allowable environmental conditions

Temperature range for use: -10 °C to +60 °C (14 °F to 140 °F)
Allowable relative humidity 0 % to 90 %, non-condensing

Unallowable environmental conditions

Mechanical vibrations or impacts.
Perspiration, urine, fresh water, salt water, acids.
Dust, sand, highly hygroscopic particles e. g. talcum.

Lifetime

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. The product was tested by the manufacturer with 2 million load cycles. Depending on the user’s activity level this corresponds to a maximum life time oaf 3 years.

Alignment recommendations and assembly

The three-dimensional arrangement of the prosthetic socket and modular elements affects the prosthesis’ static and dynamic functions. The posi tion of the residual limb must be taken into account for the connection to the socket. Plumb lines in the frontal and sagittal planes from the hip joint’s center of rotation marked during plaster cast taking and trial fitting of the test socket will facilitate correct positioning of lamination anchor or socket adapter. Recommendations for the alignment of a pelvic prosthesis consisting of Hip Joints 7E4/7E5 with Knee Joint 3R20/3R36 are shown in the diagram to the right. We recommend using the Ottobock device for alignment L.A.S.A.R. Assembly 743L200. The L.A.S.A.R. posture 743L 100 has succeeded in optimizing the alignment of the prosthesis for the patient.

Combination possibilities

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. For alignment specifications and weight limits of prosthetic feet and kneejoints, please use the operational instructions for the respective foot or kneejoint set-up.

Adjustment options

The Hip Joints 7E4 / 7E5 can be set in two planes: internal and external rotation of the prosthesis with respect to the pelvic girdle, and flexion / extension position in the sagittal plane.

Rotational positioning

Internal and external rotation can be set via the Double Hinge

The Hip Joint can be set to the desired position after loosening the four Allen head screws. A scale has been provided to facilitate adjustment. Finally, tighten the four cap screws in a cross-pattern with Torque Wrench 710D4 by app-lying M=12 Nm of torque.

Flexion / extension position

Loosen the Cap Screw 501Z2=M6x25 and slide the adjustable Extension Stop Bumper down-wards or upwards along the Thigh Tube into the desired position. Afterwards tighten the screw again with Torque Wrench 710D4 to M=13 Nm.

Service and maintenance

Check the Modular Hip Joint after several weeks and adjust if necessary.

Greasing

The Lubricating Grease 633G6 is recommended for lubricating the plastic components. The sliding metal parts such as the axes should be greased with Lubricating Paste 633F16. Make sure the Lock Rings are safely seated in their grooves and rotate them to see that they move smoothly. The four Lock Rings (507S23) must be replaced after each disassembly.

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 disregard of this document, particularly due to improper use or unauthorized modification of the product.

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