ottobock 7G3 Prosthetic Light Duty Stainless Steel Instruction Manual
- June 4, 2024
- ottobock
Table of Contents
7G3 Prosthetic Light Duty Stainless Steel
Instruction Manual
Foreword
INFORMATION
Date of last update: 2021-09-23
► 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 import and
when there is a decline in the health state.
► Please keep this document for your records.
These instructions for use provide you with important information on the pro
cessing of the 7G3, 7U2, 7U10, 7U15, 7U25, 7U26, 7U27, 7U30, 7U32, 7U33,
7U42, 7U43 and 7U46 lower leg joint bars.
Product Description
The lower leg knee joint bars are suitable for the fabrication of a
transtibial prosthesis with a thigh sleeve.
2.1 Available sizes
Lower leg joint bars
Reference number| Material| Width in mm| Thick ness in mm
7G3| Orthopaedic steel, nickel-plated| 23| 5
7U2| Orthopaedic steel| 24| 3
7U10| Orthopaedic steel| 24| 3
7U15| Orthopaedic steel, nickel-plated| 24| 3
7U25| Orthopaedic steel, nickel-plated| 24| 3
7U26| Orthopaedic steel, nickel-plated| 22| 2.5
7U27| Stainless steel| 20| 3
7U30| Stainless steel| 20| 2.3
7U32| Stainless steel| 20| 2.3
7U33| Stainless steel| 20| 2.3
7U42| Stainless steel| 20| 2.3
7U43| Orthopaedic steel| 22| 2.5
7U46| Stainless steel| 20| 1.75
2.2 Components
(see fig. 1 )
Refer ence number| Upper joint bar section (item 1)| Ball
bearing (item 2)| Joint screw (item 3)| Lock screw (item 4)|
Lower joint bar section (item 5)
7G3| | 509K11| 501A22| 501S6|
7U2| 7A1| 509K11| 501A25| 501S22| 7B3
7U15| 7A11| 509K11| 501A22| 501S6| 7B13
7U25| 7A11| 509K11| 501A22| 501S6| 7B13
(see fig. 1 )
Refer ence number| Upper joint bar section (item 1)| Ball
bearing (item 2)| Joint screw (item 3)| Lock screw (item 4)|
Lower joint bar section (item 5)
7U26| 7A12| 509K11| 501A22| 501S6| 7B12
7U30| 7A5| 509K11| 501A6| 501S22| 7B5
7U32| 7A6| 509K11| 501A6| 501S22| 7B5
7U33| 7A5| 509K11| 501A6| 501S22| 7B5
7U42| 7A6| 509K11| 501A6| 501S22| 7B5
7U43| 7A3| 509K11| 501A25| 501S22| 7B4
7U46| 7A14| 509K15| 501A12| 501S22| 7B7*
(see fig. 2 )
Refer ence number| Upper joint bar section (item 1)| Joint (item
2)| Joint screw (item 3)| Lock screw (item 4)| Ball bearing
(item 5)| Lower joint bar section (item 6)
7U10| 7A9| 7Y12| 501A24| 501S10| 509K11| 7A8
(see fig. 2 )
Refer ence number| Upper joint bar section (item 1)| Joint (item
2)| Joint screw (item 3)| Lock screw (item 4)| Bushing (not
illus treated)| Lower joint bar section (item 6)
7U27| 7A10| 7Y13| 501A32| 501S22| 7Y14*| 7B10
Intended use
3.1 Indications for use
The product is intended exclusively for use in pairs for prosthetic fittings
of the lower limbs of one patient.
3.2 Indications
- For unilateral or bilateral amputation
- Orthopaedic diseases of the lower limbs
Indications must be determined by the physician.
3.3 Lifetime
The product is designed for a lifetime of 3 years when used as intended and
assembled professionally.
3.4 Qualification
Patients may be fitted with the product only by trained qualified personnel.
The qualified personnel must be familiar with the handling of the various
techniques, materials, machines and tools.
Safety
4.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
4.2 Safety instructions
CAUTION
Excessive strain on load-bearing components Injuries due to changes in or loss
of functionality
► Only use the product for the defined area of application.
► If the product has been exposed to extreme strain (e.g. due to falling),
take any necessary measures (e.g. repair, replacement, inspection by the
manufacturer’s customer service, etc.).
CAUTION
Incorrect alignment, assembly or adjustment Risk of injury due to change in or
loss of functionality
► Assembly, adjustment and maintenance operations may only be completed by
qualified personnel.
► Observe the alignment, assembly and adjustment instructions.
CAUTION
Excessive strain due to use on more than one patient
Risk of injury and loss of functionality as well as damage to the product
► Use the product on only one patient.
► Observe the maintenance recommendations.
CAUTION
Mechanical damage to the product
Injuries due to changes in or loss of functionality
► Use caution when working with the product.
► Check the product for proper function and readiness for use.
► In case of changes in or loss of functionality, discontinue use of the
product and have it checked by authorised, qualified personnel.
NOTICE
Exposure of the product to unsuitable environmental conditions Damage,
brittleness or destruction due to improper handling
► Avoid storage in condensing ambient humidity.
► Avoid contact with abrasive substances (e.g. sand, dust).
► Do not expose the product to temperatures below -10 °C (14 °F) or above +60
°C (140 °F) (e.g. sauna, excessive sunlight, drying on a radiator).
Preparing the product for use
CAUTION
Repeated bending at the same position
Risk of injury due to breakage of the bar, change in or loss of functionality
► Avoid repeated bending at the same position.
NOTICE
Lack of parallel alignment of the joints Mechanical wear and tear
► Use the 743R3 or 743R5 parallel alignment tool.
INFORMATION
Corrosion protection of the bars
The bars are made of corrosion and acid-resistant steel. Fine grinding and
polishing improve the corrosion protection of the bars. Ottobock recommends
the 618T40 sintering powder for coating.
Shaping the bars
Required tools : 743R3 or 743R5 parallel alignment tool, 711S5 bend ing irons.
-
Check the alignment of the bars on the model.
-
Disassemble the joint.
-
Adapt the bars with the bending irons.
NOTICE: Do not damage the surface hardened toothed segments of the 7U10 and 7U27 joints.
-
Check the adaptation of the model.
-
Repeat the steps until the desired result is obtained.
-
Remove grooves and burrs by grinding.
Finishing the surfaces of the 7U46 bars
The 7U46 knee joint bars can be used in a waterproof walking aid.
► Polish the surfaces of the bars on all sides.
Improving corrosion protection
Polish or sinter the product for improved corrosion protection. Ottobock recommends the 618T40* sintering powder for surface coating.
► Do not heat the material longer than 5 minutes at max. 150 °C for sur face coating.
Using protective devices
► Use joint protectors to protect the product against soiling.
6 Cleaning
Promptly clean the product after contact with water containing salt, chlorine or soap, or if it gets dirty.
- Rinse the product with clear fresh water.
- Dry the product with a cloth or allow it to air dry. Avoid exposure to direct heat (e. g. from an oven or radiator).
Maintenance
INFORMATION
The product may be exposed to increased loads by the patient.
► Shorten the maintenance intervals according to the expected loads.
The manufacturer requires at least a semi-annual inspection of the product to
verify functionality and check for wear.
Only use 633F7 special lubricant.
Replacing the ball bearing
NOTICE
Canting the ball bearing
Mechanical damage
► Do not cant or damage the ball bearing while inserting it into the orthot
ic joint.
- Loosen the screws and disassemble the orthotic joint.
- Remove the ball bearing from the orthotic joint and replace it with a new one.
- Assemble the orthotic joint and tighten the screws.
- Lock screw: Clean the threads of the screw connections using a degreasing cleaner and secure them with Loctite 241.
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.
9.1 Liability
The manufacturer will only assume liability if the product is used in accord
ance 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 unauthor
ised modification of the product.
9.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medic all
devices. The CE declaration of conformity can be downloaded 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
© Ottobock · 647G1669=all_INT-03-2110
Documents / Resources
|
ottobock 7G3 Prosthetic Light Duty Stainless
Steel
[pdf] Instruction Manual
7G3, 7U2, 7U10, 7U15, 7U25, 7U26, 7U27, 7U30, 7U32, 7U33, 7U42, 7U43, 7U46,
7G3 Prosthetic Light Duty Stainless Steel, 7G3, Prosthetic Light Duty
Stainless Steel
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