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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.

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  consulta­
tions.

Conduct annual safety inspections.

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.

Lubrication

14

  on page 8: Do not lubricate or grease the prosthetic joint.

Replacing components

CAUTION

Improper assembly of the screw connections

Risk  of  injury  due  to  breakage  or  loosening  of  the  screw  connec­
tions

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.

15

When 

necessary, 

remove 

worn 

brake 

bushing

(4B74=20.4X24.5-K) as shown in the illustration 

15

 on page 9.

To reassemble, perform these steps in reverse order.

In doing so, note the following points:

 Ensure the correct assembly of the bushing safety device.

 Clean  the  knee  axis  with  isopropyl  alcohol  (  634A58)

before assembly.

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.

1 Информация по данному документу

Русский

ИНФОРМАЦИЯ

Дата последней актуализации: 2021-01-22

Содержание 3R15

Страница 1: ...Instructions for use 10 15 3R15 3R49...

Страница 2: ...21Y113 2 21Y66 513D28 2x 21Y67 506G1 M8x25 3R15 3R49 5 Scope of delivery 1 3R15 3R49 490 g 360 g 75 mm 150 Proximal system height Distal system height h s prox 8 mm hs dist 1 mm 1 2 100 kg 220 lbs kg...

Страница 3: ...30 mm a 5 mm a 0 mm 50 50 0 mm 30 mm 10 mm 20 mm 7 2 Bench alignment of the prosthesis 3 m l p a 5 7 m l p a 5 0 mm 50 50 7 2 Bench alignment of the prosthesis 4 3...

Страница 4: ...4 mm 7 2 Bench alignment of the prosthesis 5 Spina iliaca anterior superior mm 0 20 mm 0 20 mm 0 20 mm 40 7 3 Optimising the static alignment 6 4...

Страница 5: ...0 mm 4 mm 7 4 Optimising during dynamic trial fitting 7 6 mm 0 mm 0 mm 7 4 Optimising during dynamic trial fitting 8 5...

Страница 6: ...lly Minimal braking action 45 45 7 4 Optimising during dynamic trial fitting 9 Increase threshold Joint brakes at a higher load Reduce threshold Joint brakes at a lower load 7 4 Optimising during dyna...

Страница 7: ...ncrease resistance to motion Increase play Decrease resistance to motion 7 4 Optimising during dynamic trial fitting 11 Increase spring tension Reduce spring tension 7 4 Optimising during dynamic tria...

Страница 8: ...Alternative positioning Recommended positioning 7 5 Finishing the prssthesis 13 Do not lubricate and grease the prosthetic joint 9 Maintenance 14 8...

Страница 9: ...6 mm 634A58 Isopropyl alcohol 4B74 20 4X24 5 K 25 Nm 0 mm 9 Maintenance 15 9...

Страница 10: ...2 Product description The product 3R15 3R49 has the following key features Monocentric prosthetic knee joint Product components for stance phase stability Adjustable load dependent braking mechanism t...

Страница 11: ...environmental conditions in this section If the product was exposed to unallowable environmental condi tions take suitable steps e g cleaning repair replacement inspection by the manufacturer or a spe...

Страница 12: ...2 on page 2 Proximal system height PSH distal system height DSH 12 7 Preparing the product for use 7 1 Information on fabrication of a prosthesis CAUTION Incorrect alignment assembly or adjustment Inj...

Страница 13: ...kes at a higher load Reduce threshold Joint brakes at a lower load Increase gradually rotation approx 45 90 13 When the desired effect is reached continue with Setting axis friction Setting axis frict...

Страница 14: ...cover 3R6 3S106 After affixing the cosmetic elements verify proper functioning of the prosthesis To reduce friction and to eliminate noise apply silicone spray dir ectly onto the contact surfaces of t...

Страница 15: ...s before every installation Apply the specified torque values Follow the instructions regarding the length of the screws and about how to secure the screws 15 When necessary remove a worn brake bushin...

Страница 16: ...1 1 1 2 1 1 1 J 2 3R15 3R49 16 3R15 3R49 3 3 1 3 2 3R15 1 2 100 kg 1...

Страница 17: ...2 3 3 17 3 4 10 C 60 C 0 90 100 250 1100 3 5...

Страница 18: ...3 5 4 18 5 1 2 6 2 2 PSH DSH 7 7 1...

Страница 19: ...7 2 3 3 4 3 5 4 7 3 19 6 4 Spina iliaca anterior superior 6 4 7 4 7 8 9 5 6 9 6 45...

Страница 20: ...10 6 45 90 11 7 20 12 7 20 7 5 13 8...

Страница 21: ...7 5 1 3R6 3S106 8 8 1 21 8 2 1 2 3...

Страница 22: ...9 30 14 8 22 4B74 20 4X24 5 K 15 9 634A58 10 11 11 1...

Страница 23: ...11 2 2017 745 CE 23...

Страница 24: ...45043 20 7 8482 75 85 81 info ottobock ru www ottobock ru 143441 69 7 7 495 564 83 60 7 495 564 83 63 info ottobock ru www ottobock ru Ottobock SE Co KGaA Max N der Stra e 15 37115 Duderstadt Germany...

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