Otto Bock Dynion 3R85 User manual

Instructions for use ......................................................................................................... 3
Dynion 3R85

2

Notes regarding the document1 4.....................................................................................
Explanation of warning symbols1.1 4..............................................................................
Meanings of pictograms in the illustration1.2 4................................................................
Characteristics (product, document)1.3 5......................................................................
Document versions1.4 6...............................................................................................
Product description2 7.......................................................................................................
Intended use3 7...................................................................................................................
Indications for use3.1 7................................................................................................
Area of application3.2 7...............................................................................................
Combination possibilities3.3 8......................................................................................
Environmental conditions3.4 9......................................................................................
Reuse and lifetime3.5 10..............................................................................................
General safety instructions4 10.........................................................................................
Scope of delivery5 11..........................................................................................................
Technical data6 12..............................................................................................................
Preparing the product for use7 14.....................................................................................
Information on fabrication of a prosthesis7.1 14..............................................................
Manufacturing the bench alignment7.2 14......................................................................
Optimising the static alignment7.3 19............................................................................
Optimising during dynamic fitting7.4 21.........................................................................
Notices regarding dynamic fitting7.4.1 21.........................................................................
Overview of adjustment possibilities7.4.2 22......................................................................
Checking the initial settings for the dynamic fitting7.4.3 29..................................................
Switching between the stance phase and swing phase7.4.4 31...........................................
Exercises and adjustments7.4.5 33...................................................................................
Attaching the cosmetic cover7.5 43...............................................................................
Finishing the prosthesis7.6 45......................................................................................
Use8 46.................................................................................................................................
Information for use8.1 46..............................................................................................
Cleaning8.2 48...........................................................................................................
Maintenance9 49.................................................................................................................
Disposal10 50.........................................................................................................................
Legal information11 51.........................................................................................................
Liability11.1 51.............................................................................................................
CE conformity11.2 51....................................................................................................
Table of contents
3

1 Notes regarding the document
INFORMATION
Date of last update: 2022-05-07
►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 prob
lems.
►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 qual
ified personnel with technical knowledge of lower limb prosthetics.
1.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
1.2 Meanings of pictograms in the illustration

1
Numbering for the illustrations Reference to the section for the illustration

1
Numbering for a defined sequence 
1
Numbering for the parts of an illustration

J
Right Wrong
Observe the safety notice in the section! Risk of falling
Replace Movement against a stop
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1.3 Characteristics (product, document)
1
:The following characteristics are important for identification:
• :3R85 [product reference number]
• :YYYYWWNNNN [product serial number: YYYY(year of manufacture); WW(calendar
week); NNNN(number)]
• :647G1166=all_INT-VV-YYMM [standard line for the document: 647G1166=all_INT(refer
ence number for the document); VV(version number); YYMM(publication date) – YY(year);
MM(month)]
1

6
1.4 Document versions
2
:The document is available in the following versions:
• :647G1166=all_INT (document reference number with all available languages)
All illustrations in this document are found at the beginning. They are followed by the texts in
all languages.
This printed document is included in the scope of delivery.
This document is available in electronic form (PDF file).
• :647G1166=XX_INT (document reference number as single-language version)
647G1166=en_INT (example of single-language version in en=English)
All illustrations in this document are found in the respective sections.
This document is available in electronic form (PDF file).
• XX (variable for the language codes of the languages in which the single-language version
is available)
The documents in electronic form are available as follows:
• Download via the manufacturer's download portal under the QR code and link provided
https://product-documents.ottobock.com/IFU/INT/3R85/647G1166/11/O/S/F
2
The following additional documents are available in electronic form (PDF file):
• 646D1504=de_INT (Kurzanleitung)
• 646D1504=en_INT (Quick reference guide)

7
2 Product description
The product(3R85) has the following key features:
• Monocentric prosthetic knee joint with rotation hydraulics
• Product components for stance phase stability:
- Adjustable stance phase flexion resistance (hydraulic damping)
- Adjustable switching threshold to deactivate stance phase flexion resistance at the end of
the stance phase
- Modes (switching by the patient):
Standard mode – stance phase flexion resistance activated
Cycling mode – stance phase flexion resistance deactivated
- Lock (activation and deactivation by the patient)
• Product components for swing phase control:
- Adjustable swing phase flexion resistance (hydraulic damping)
- Adjustable swing phase extension resistance (hydraulic damping)
- Hydraulic unit with extension assist function (spring force)
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 (3R85)
Recommended mobility grade:3 + 4
Allowable body weight:≤ 100 kg
Everyday prosthesis

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3.3 Combination possibilities
CAUTION
Improper combination of prosthetic components
Injuries, malfunctions or product damage due to unallowable combination of prosthesis compo
nents
►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
:Recommended combinations | Unallowable combinations
►Note the image for the recommended combinations and unallowable combinations.
3R857E10*3R857E77E93R85Triton 1C60*Triton Vertical Shock 1C61*Triton Harmony 1C62*Triton Low Profile 1C63*Triton Heavy Duty 1C64*Triton side flex 1C68*Meridium 1B1*Empower 1A1-1*29-3029-3029-3029-3029-3029-3026-2928-304R57=WR4R57=WR-STTaleo, Taleo LP 1C50*, 1C53*Greissinger plus 1A30*Dynamic Motion 1D35*Terion 1C10*Trias 1C30*C-Walk 1C40*Triton 1C60*Triton Vertical Shock 1C61*Triton Harmony 1C62*Triton Low Profile 1C63*Triton Heavy Duty 1C64*Triton side flex 1C68*Meridium 1B1*Empower 1A1-1*Axtion 1E56*21-2821-2821-2821-2821-2821-2824-2525-27
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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 "Unallow
able 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:
Storage + Transportation (in original packaging): -20°C–+60°C
Always store in a dry place.
Use: -10°C–+45°C
Relative humidity: 20%–90%
Contact with drops of water (fresh water, light rain)
Drying is required after contact.
Contact with soapy water in the form of splashed water (showering); contact with perspiration
Submersion in chlorinated water (e.g. pool) – maximum depth:2m
Rinsing with clean fresh water and drying is required after contact.
Submersion in salt water with permissible salt content
• Salt content: max.3.5%
• Maximum depth: pool:1m, ocean:0.5m
Thorough rinsing with or immersing in clean fresh water and drying is required after contact
(section "Cleaning" – see page48).
An inspection by qualified personnel (prosthesis manufacturer) is required after use (days per
year:14).
An inspection by service (prosthetic knee joint manufacturer) is required in case of damage and
functional limitations.
Contact with dust, foam cover particles, drifting sand (e.g.walking on the beach)
Regular cleaning is required.
Contact with salty air – condensing
Rinsing with clean fresh water and drying is required after contact.
UV resistant
Cleaning with damp cloth (fresh water + commercially available, solvent-free cleaning agent)
Unallowable environmental conditions
Contact with hygroscopic particles (example: talcum); contact with large amounts of sand and
dust (e.g.burying, kneeling in sand, construction site); contact with acids; contact with urine;
submersion in salt water with excessive salt content
• Salt content: >3.5% – e.g.brine bath
Cleaning agents and disinfectants with solvents, chlorine and phosphate
High water pressure (e.g.diving, jumping into water)

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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 prosthetic component has been load tested by the manufacturer according to ISO10328.
The maximum lifetime is 5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 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.

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5 Scope of delivery
4
:Check the scope of delivery against the illustrations.
Only product components with reference numbers in the illustration can be reordered separately.
A product component without a reference number in the illustration cannot be reordered separ
ately.
Reference numbers in brackets "()" indicate which alternative products can be reordered as
replacements for the included product component.
In the illustration, a reference number shown in bold stands for a spare parts package in which
the product components shown in the frame can be reordered.
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6 Technical data
5
+
6
:See the illustrations for the technical data.
100 kg220 lbs1240 gkg
m°
5

13
:Build height; :Proximal build height; :Distal build height;
:System height; :Proximal system height; :Distal system height
Ø 30 mm145°231 mm44,5 mm172 mm216,5 mm26,5 mm120 mm–133 mm147 mm–160 mm
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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 pros
thesis
►For the safety of the patient, use a suitable device (e.g.parallel bars, handrail, wheeled
walker) during initial standing and walking.
7.2 Manufacturing the bench alignment
►
7
+
8
:CAUTION!To enable the patient to stand safely, align the prosthesis using the
alignment images as well as the instructions for use of all prosthetic components used.
►During activation and deactivation of the lock, push the prosthetic knee joint against the exten
sion stop.
►Perform the bench alignment of the prosthesis with the prosthetic knee joint locked.
►INFORMATION:The posterior section of the prosthetic knee joint can be used as a flexion
stop for the prosthetic socket.
NOTICE!Design the prosthetic socket so that nothing made of metal presses against the pos
terior section of the prosthetic knee joint.
a + 5 mm50%a0 mm20 mm0 mm30 mm50%50%50%50%50%30 mm
7

15
0 mm50%50%mlpa5°mlpa5 – 7°
8

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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.
Adapter inserts
►
9
:Mount the adapter inserts shown in the illustration when using an alignment apparatus.
→:The prosthetic knee joint reference numbers shown in square brackets are marked on
the adapter inserts. The adapter insert reference numbers and mm dimensions in the
round brackets are not found on the adapter inserts.
[3R80, 3R106=HD, =KD, =ST]743Y580 (0 mm)
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Installing the tube adapter
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 for thread lock.
CAUTION
Incorrect processing of the tube
Fall due to damage to the tube
►Do not clamp the tube in a vice.
►To shorten the tube, use only a tube cutter or a cutting device.
►Deburr the inside and outside of the cut edge with the tube deburrer.
CAUTION
Incorrect assembly of the tube
Risk of injury due to breakage of load-bearing components
►Clean the contact surfaces of the tube and the tube adapter using a degreasing cleaning
agent.
►Note the values identified as permissible and impermissible in the illustration for positioning
the tube in the tube adapter.

18
►
10
:CAUTION!Position and clamp the tube adapter only as shown in the illustration.
→:Impermissible value:>13mm
→:Permissible value:0–13mm
→:Recommended value:0mm
0 – 13 mm12.12.213 mm0 mm>13 mm704Y14=30719R421.2718R11.11.32.310 Nm4 mmLOCTITE3
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7.3 Optimising the static alignment
INFORMATION:Additional technical knowledge is provided by the instructions for use of the
measuring apparatus being used, the TF alignment poster and the Ottobock seminars.
The 743L500 3D L.A.S.A.R. Posture measuring apparatus is needed to optimise the static align
ment.
The following optimisation methods are available:
• :Optimisation with 3D mode activated
• :Optimisation with 3D mode deactivated
The optimisation method can be used as an optional second step.
With the 743L100 L.A.S.A.R. Posture, optimisation is possible only based on the values of the
optimisation method .

20
11
: :Optimisation with 3D mode activated
►Optimise the static alignment so the patient stands in a relaxed position, the values for the ref
erence points shown in the illustration are met and the following points are observed:
• :3D mode is activated (3D symbol – colour:green).
- Sequence for optimisation in reference to the planes:
.
:Sagittal plane –
.2
:Frontal plane
• :The prosthetic knee joint is in extension. The lock is activated.
• :The reference line lies on the sagittal reference point of the prosthetic knee joint (pivot
point).
• :The reference points are in the centre (50:50: pyramids of the prosthetic knee joint and
the prosthetic foot, shoes).
• :The extension of the reference line points to the reference point (anterior superior iliac
spine).
• :The reference line lies on the frontal reference point of the prosthetic knee joint (pyramid).
743L500 3D L.A.S.A.R. Posture1.11.2Spina iliaca anterior superior
20 mm20 mm50 % : 50 %10 mm10 mm40 – 60 mm40 – 60 mm
Live view121.0 Nm1.0 Nm50.0 %50.0 %
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