Otto Bock 3E80 User manual

3E80
Instructions for use ......................................................................................................... 6
Istruzioni per l’uso .......................................................................................................... 17
Instrucciones de uso ...................................................................................................... 28
Manual de utilização ....................................................................................................... 41
Instrukcja użytkowania .................................................................................................... 52
Használati utasítás ......................................................................................................... 64
Návod k použití .............................................................................................................. 75
Руководство по применению ......................................................................................... 86
取扱説明書 .................................................................................................................... 99
使用说明书 .................................................................................................................... 110
사용 설명서 ................................................................................................................... 119

1
234
5
4
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567
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0 mm
x + 5 mm
30 mm
Línea de
alineamiento
Linha de
montagem
Alignment reference
line
체중부하선アライメント基準線Ось сборки
Felépítővonal
8
3

Load line
Línea de carga
Linha de carga
ၨᅰთഎ໓Ось нагружения
Terhelésvonal
9
4

10 11 12
13 14 15
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1 Product description English
INFORMATION
Last update: 2020-01-16
►Please read this document carefully before using the product.
►Follow the safety instructions to avoid injuries and damage to the product.
►Instruct the user in the proper and safe use of the product.
►Please keep this document in a safe place.
1.1 Construction and Function
The 3E80 prosthetic knee joint is a hydraulic prosthetic knee joint with rotation hydraulics and an
electronically controlled stance phase control. A microprocessor evaluates the signals from the
sensors installed in the prosthetic knee joint and also controls the hydraulic system.
The electronic control automatically adjusts to the patient and does not need to be adjusted by an
O&P professional. Flexion damping, extension damping and stance phase damping can be adjus
ted individually. This not only makes it possible for the patient to walk comfortably at a wide range
of speeds, the patient can also walk step-over-step over sloping surfaces, uneven terrain and
down stairs. The prosthetic knee joint also features a bicycling mode. The prosthetic knee joint
switches over to a safety mode with high flexion resistance when its battery is empty or when the
device malfunctions.
1.2 Combination possibilities
This prosthetic component is compatible with Ottobock's system of modular connectors. Func
tionality with components of other manufacturers that have compatible modular connectors has
not been tested.
Limited combination options for Ottobock components
Designation Reference number
Prosthetic feet 1D35, 1C30, 1C40, 1C50, 1E56, 1E57, 1C60,
1C61, 1C62, 1C63, 1C64
Tube adapters 2R58, 2R77
Socket adapters (examples) 4R41, 4R51, 4R55, 4R111, 4R119
Foam cover 3S107
2 Intended use
2.1 Indications for use
The product is to be used solely for lower limb prosthetic fittings.
The product is only suitable for prosthetic fitting after a transfemoral amputation and after knee
disarticulation.
2.2 Area of application
Our components perform optimally when paired with appropriate components based upon weight
and mobility grades identifiable by our MOBIS classification information and which have appro
priate modular connectors.
°
kg
The product is recommended for mobility grade3 (unrestricted outdoor walker)
and mobility grade4 (unrestricted outdoor walker with particularly high demands).
Approved for a body weight of up to 125kg(275 lbs).
6

7
2.3 Environmental conditions
Allowable environmental conditions
Temperature range for use: -10°C to +60°C
Relative humidity: 15% to 93%, non-condensing
Air pressure: 700hPa to 1060hPa
Storage and transport temperature range:−25°C to +65°C
Moisture: fresh water as splashing water
Unallowable environmental conditions
Mechanical vibrations or impacts
Perspiration, urine, salt water, acids
Sand, highly hygroscopic particles (e.g. talcum)
2.4 Service life
This prosthetic component has been tested by the manufacturer for 3 million load cycles accord
ing to ISO 10328. Depending on the patient's activity level, this corresponds to a service life of 3
to 5 years.
3 Safety
3.1 Explanation of warning symbols
WARNING Warning regarding possible serious risks of accident or injury.
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
3.2 General safety instructions
WARNING
Operation of motor vehicles
Risk of accidents due to restricted body function
►Observe the applicable legal and insurance regulations for the operation of motor vehicles
and have your driving ability examined and certified by an authorised agency.
CAUTION
Excessive strain on the product
Risk of injury due to breakage of load-bearing components
►Use the prosthetic components according to the MOBIS classification.
CAUTION
Unallowable combination of prosthetic components
Risk of injury due to breakage or deformation of the product
►Only combine the product with prosthetic components that are approved for that purpose.
►Based on the instructions for use of the prosthetic components, verify that they may be com
bined with each other.

8
CAUTION
Use under unallowable environmental conditions
Risk of injury due to damage to the product
►Do not expose the product to unallowable environmental conditions.
►If the product has been exposed to unallowable environmental conditions, check it for dam
age.
►If damage is apparent or in case of doubt, do not continue using the product.
►Take suitable measures if required (e.g.cleaning, repair, replacement, inspection by the
manufacturer or a specialist workshop etc.).
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.).
CAUTION
Exceeding the service life and reuse on another patient
Risk of injury due to loss of functionality as well as damage to the product
►Ensure that the approved service life is not exceeded.
►Only use the product on a single patient.
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 daily use.
►Close attention is required during assembly and adjustment tasks.
NOTICE
Mechanical overload
Impaired functionality due to mechanical damage
►Check the product for damage prior to each use.
►Do not use the product if its functionality has been impaired.
►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
Noticeable changes in functionality may include poor response, incomplete extension, diminished
swing phase control or stance phase stability, abnormal noises, etc.
4 Scope of delivery
Fig. Item Quantity Designation Reference number
– – 1 Instructions for use –
1 1 1 Prosthetic knee joint –

9
Fig. Item Quantity Designation Reference number
1 2 1 Universal power supply 757L16*
1 3 1 Charging unit 4G497
1 4 1 Adjustment wrench 710H10=2x3
Single-component pack, consisting of: 4G520
5 1 Lithium-ion battery –1
6 4 Battery mounting screws 501S84=M3x8
Single-component pack, consisting of: 4G513=SET
1 7 3 Front inlay –
5 Preparation for use
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 per
sonnel.
►Observe the alignment, assembly and adjustment instructions.
CAUTION
Use of talcum
Risk of injury, damage to the product due to lack of lubrication
►Do not use talcum on the product or other prosthesis components.
CAUTION
Incorrect mounting of the tube
Risk of injury due to breakage of load-bearing components
►Slide the tube all the way to the stop in the intended prosthetic component when mounting.
5.1 Charging the battery
CAUTION
Connecting the battery charger while a battery is not inserted
Fall due to prosthetic knee joint being automatically reset to factory settings
►Only connect the battery charger to the prosthetic knee joint when the battery is inserted.
CAUTION
Using the prosthesis during the charging process
Fall due to connected charging cable
►Take the prosthesis off before charging the battery.
►Disconnect the prosthesis from the battery charger before putting it on.
INFORMATION
The battery is not fully charged upon delivery. The battery must be charged before the product is
used for the first time.
Ottobock recommends charging the prosthetic knee joint daily overnight. The charging process
can last up to 3hours and may only be performed within the prescribed charging temperature

10
range. An electronic unit protects the battery from being overcharged. The power supply and bat
tery charger will heat up during the charging process.
INFORMATION
Battery life for a fully charged battery is:
Up to 96 hours in normal mode.
Up to 4 hours in bicycling mode.
The capacity of the battery decreases over the course of the product's operational life and with
the number of charging processes performed.
►Replace the battery when battery life becomes noticeably reduced or when the battery
replacement signal is emitted.
The charging process and battery status are indicated by signals on the prosthetic knee joint
(light, sound, vibration) and battery charger (light) (see fig.5). The brightness of the light signals
adjusts to the ambient light. The signals are listed in the following table.
Notification Vibration signal Light signal Audible signal
Product activation
(when battery is inser
ted)
1x vibration impulse LED 3 lights up briefly, all
LEDs light up briefly
1 x signal tone, rising
Connecting battery
charger, charging bat
tery
1x vibration impulse LEDs light up, rising, during
the charging process: 1, 2, 3,
4, 5
1 x signal tone, rising
Disconnecting battery
charger, when battery is
fully charged
1x vibration impulse All LEDs light up for approx. 5
sec
1 x signal tone, short
Disconnecting battery
charger, when battery
not fully charged
1x vibration impulse LEDs 1, 2 light up for approx.5
seconds
1 x signal tone, short
Charging error (pros
thetic knee joint is not
charging)
If the battery is not
defective, several short
vibration signals
LEDs 1, 3, 5 light up for sever
al seconds
Signal tone, continu
ous
Battery defective or not
installed or reset to
factory default settings
– LED 3 lights up briefly, all
LEDs flash for several seconds
1 x signal tone, rising
1 x signal tone, siren
3 x signal tone, short
Battery capacity low 3 x vibration signal,
short
LEDs light up for several
seconds: 1, 3, 5 alternating
with 2, 4
3 x signal tone, short
Battery drained, switch
ing to safety mode
6 x vibration signal,
short
LEDs light up for several
seconds: 1, 3, 5 alternating
with 2, 4
6 x signal tone, short
Battery replacement
required
– LEDs light up, alternately
bright then dimmed
6xsignal tone, high
and short, 1xsignal
tone, low and short
Assembling the battery charger
>Required materials:
4G497 charging unit, 757L16* power supply
►Connect the charging unit to the power supply (see fig.6).
Charging the battery
1) Plug the battery charger plug into the outlet.
2) Carefully insert the charging plug into the charging receptacle on the prosthetic knee joint
(see fig.7).
3) If the device signals a charging fault, disconnect and then reconnect the charging plug.

11
4) Disconnect the charging plug before using the prosthesis.
5.2 Alignment
The three-dimensional alignment of the prosthesis components affects the function of the pros
thesis. The patient can use the prosthesis to its fullest potential only with correct alignment.
Alignment requires the following steps:
• Bench alignment of the prosthesis in the alignment apparatus.
• Static alignment with the patient, to check and correct the alignment of the components.
• Dynamic trial fitting for optimisation and individual adjustment of the prosthesis components.
• If necessary, the alignment recommendations (TF modular leg prostheses: 646F219*, TT
modular leg prostheses: 646F336*) may be requested from Ottobock.
5.2.1 Bench Alignment
Bench alignment process (see fig.8)
Required tools and materials: 662M4 goniometer, 743S12 heel height measuring
device, 743A80 50:50gauge, alignment tool (e.g. 743L200 L.A.S.A.R. Assembly or
743A200 PROS.A. Assembly)
Perform the assembly and alignment of the prosthetic components in the alignment
tool according to the following specifications:
  a–ppositioning, middle of the prosthetic foot to the alignment reference line:
+30mm
Heel height: Effective heel height (shoe heel height – sole thickness of forefoot)
+5mm
 
Exterior foot rotation: approx.5°
Positioning of the alignment reference point (rotation axis of the prosthetic knee joint)
in the alignment apparatus:
MTP-floor measurement + 20mm
a–ppositioning of the alignment reference point to the alignment reference line:
0mm
 
External rotation of the prosthetic knee joint:
approx.5°
  Prepare the tube adapter. Observe the adapter instructions for use during adaptation
and installation.
Clean the tube adapter with a degreasing cleaner and insert it in the prosthetic knee
joint to the stop (see fig.10). Tighten the cap screw in the clamping (tightening
torque: 10Nm) (see fig.11).
Join the prosthetic foot with the prosthetic knee joint using the tube adapter.
  Mark 2 centre points laterally on the prosthetic socket:
1. At the level of the greater trochanter
2. In the distal region
Join the two points with a line.
  Position the prosthetic socket so its proximal point lies on the alignment reference line.
Socket flexion: Individual residual limb flexion +5°
  Join the prosthetic socket and the prosthetic knee joint using the adapters selected.
Be sure to follow the adapter instructions for use during adjustment and installation.

12
5.2.2 Static Alignment
Static alignment process (see fig.9)
Required materials and tools:
743L100 L.A.S.A.R. Posture
  To determine the load line, position the patient on the L.A.S.A.R. Posture as follows:
• Prosthesis side on force measurement plate (sufficient load: >35% body weight)
• Other side on height compensation plate
  Optimise the static alignment solely by changing the plantar flexion.
a–p positioning of the alignment reference point (rotation axis of the prosthetic knee
joint) to the load line:
-35 mm
5.2.3 Dynamic Trial Fitting
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 daily use.
►Close attention is required during assembly and adjustment tasks.
CAUTION
Dynamic trial fitting without parallel bars
Fall due to lack of patient experience or functional changes
►Perform the dynamic trial fitting using parallel bars when the prosthesis is first used and also
after any change is made to the prosthesis.
During dynamic trial fitting, the alignment and settings of the prosthesis are checked and adapted
for optimum walking according to the needs and abilities of the patient.
Electronic control for switching between stance phase and swing phase is calibrated within the
first 20steps.
5.2.3.1 Setting flexion and extension damping
INFORMATION
The valves for flexion and extension are located under the cover at the front of the prosthetic
knee joint.
The desired gait pattern is achieved by adjusting the damping behaviour of the prosthetic knee
joint for flexion and extension in the swing phase.
Valve Symbol Factory setting (damping)
Flexion valve (F) Minimum
Extension valve (E) Minimum
>Required tools and materials:
710H10=2x3 adjustment wrench
1) Use the adjustment wrench to set the flexion resistance (see fig.12).
2) Use the adjustment wrench to set the extension resistance (see fig.13).
Situation Measures Setting
Lower leg swings through too far Increase damping Turn flexion valve to the right (+)
Lower leg does not swing through
sufficiently
Reduce damping Turn flexion valve to the left (–)

13
Situation Measures Setting
Lower leg impact too hard on the
extension stop
Increase damping Turn extension valve to the right (+)
Lower leg does not reach full
extension before heel strike
Reduce damping Turn extension valve to the left (–)
5.2.3.2 Setting Stance Phase Damping
INFORMATION
The stance phase valve is located under the cover at the front of the prosthetic knee joint.
Stance phase damping influences the amount of resistance put up by the prosthetic knee joint
against a bending under load. Stance phase damping is used in order to sit down, walk down
stairs step-over-step and walk down sloping surfaces.
Valve Symbol Factory setting (damping)
Stance phase valve (S) Maximum
>Required tools and materials:
710H10=2x3 adjustment wrench
►Adjust stance phase damping (see fig.14). Adjust stance phase damping in various situations
(sitting down, walking down stairs, walking down a sloping surface).
Situation Measure Adjustment
Stance phase damping too strong Reduce damping Turn stance phase valve to left (–)
Stance phase damping too weak Increase damping Turn stance phase valve to right
(+)
5.3 Troubleshooting
The prosthetic knee joint does not switch to swing phase
> The patient cannot initiate the swing phase. The prosthetic knee joint is sticking or is locked, a
toe-off is not possible.
1) Check the battery charge level and charge the battery if necessary.
2) Make sure the prosthesis is sufficiently loaded from when the middle stance phase begins.
3) Check the alignment of the prosthesis. Make sure the socket flexion is sufficient.
4) Reset the prosthetic knee joint to factory settings (see Page13).
5) Perform a dynamic trial fitting.
The prosthetic knee joint does not switch to stance phase damping
> The patient cannot activate stance phase damping. The prosthetic knee joint does not switch
from swing phase to stance phase damping.
1) Make sure the prosthetic knee joint is in normal mode.
2) Reset the prosthetic knee joint to factory settings (see Page13).
3) Perform a dynamic trial fitting.
The prosthetic knee switches over to swing phase too soon
> The prosthetic knee joint switches over to swing phase while the patient is standing and the
forefoot is bearing weight, or switches over too soon while the patient is walking.
1) Check the static alignment of the prosthesis. Make sure the plantar flexion is set correctly.
2) Reset the prosthetic knee joint to factory settings (see Page13).
3) Perform a dynamic trial fitting.
5.3.1 Resetting to factory settings
> The prosthesis is completely aligned, the prosthetic knee joint battery charger is ready.
> The patient has taken off the prosthesis.
1) Remove the battery from the prosthetic knee joint (see Page15).

14
2) Close the cover at the front of the prosthetic knee joint.
3) Place the extended, unloaded prosthesis on an underlying base.
4) Connect the battery charger to the prosthetic knee joint.
→A signal tone will be emitted. The resetting process will start automatically after the signal
tone ends.
→Three signal tones will confirm the process has ended. The control settings for the pros
thetic knee joint are now reset to their factory settings.
5) Disconnect the battery charger from the prosthetic knee joint.
6) Insert the battery into the prosthetic knee joint (see Page15).
→A signal tone will be emitted to indicate the prosthetic knee joint is ready for operation. The
control unit has to adjust to the patient by means of trial walking.
6 Use
INFORMATION
Remove the battery if the product will not be used for an extended time (>2months).
6.1 Safety mode
NOTICE
Contact of the product with a magnet
Functional limitations due to sensor malfunction
►Do not bring the product into contact with magnets.
Safety mode is activated when the battery is almost drained or a system error occurs. Safety
mode activates stance phase damping permanently and thereby allows walking safely.
Switching to safety mode is indicated by signals (light, sound, vibration).
If safety mode has been activated due to an empty battery or a minor fault, the prosthetic knee
joint switches back to normal mode when the battery charger is plugged in.
6.2 Cycling mode
Cycling mode makes it possible to ride a bicycle with low flexion damping. Switching between the
modes (normal mode, cycling mode) is triggered by a movement pattern.
1) Bounce up and down on the forefoot 3x in quick succession while maintaining continuous
ground contact (see fig.15). In this process, apply load to the foot to mimic walking then
noticeably ease the load in between steps without removing the foot from the floor.
→Vibration signals and signal tones will indicate the upcoming change to the desired mode.
2) To switch modes, lift up the prosthesis for at least 2 seconds then extend it toward the rear
without making contact with the floor (see fig.16).
→The prosthetic knee joint confirms the switching process and switches to the other mode.
A dropping signal tone indicates a fault in the switching process.
Mode change Vibration signal Light signal Audible signal
Normal mode to bicycling
mode
2 x vibration signal, short All LEDs flash for several
seconds
1 x signal tone, long
2 x signal tone,
short
Bicycling mode to normal
mode
1 x vibration signal, short All LEDs flash for several
seconds
1 x signal tone, long
1 x signal tone,
short

15
6.3 Warning signals
CAUTION
Overheating of the hydraulics due to excessive strain
Burns, injuries caused by falling due to changes in functionality and damage to prosthetic com
ponents
►Do not touch overheated prosthetic components.
►Reduce all activities if there are changes in functionality, in order to allow the overheated
prosthetic components to cool down.
►If overheating or changes in functionality occur, have the prosthesis checked by authorised
qualified personnel.
Warning signals
Notification Vibration signal Light signal Audible signal
Overheating warning 3 × vibration signal, long LEDs light up for several
seconds: 1, 5 alternating
with 2, 3, 4
5 × signal tone,
ringing
Overheating (prosthetic
knee joint no longer func
tional)
10 x vibration signal,
short
LEDs 3, 4, 5 light up for
several seconds
Signal tone, con
tinuous
System fault (prosthetic
knee joint no longer func
tional)
10 x vibration signal,
short
LED signal depends on
error
Signal tone, con
tinuous
7 Cleaning
NOTICE
Use of unsuitable cleaning agents
Damage to the product (e.g. bearings, seals and plastic components) due to substances con
tained in the cleaning agent
►Do not use any harsh cleaning agents.
1) Clean the product with a damp, soft cloth.
2) Dry the product with a soft cloth.
3) Allow to air dry in order to remove residual moisture.
8 Maintenance
►NOTICE! Repair work must be performed exclusively by manufacturer service.
►A visual inspection and functional test of the prosthetic components should be performed
after the first 30days of use.
►Inspect the entire prosthesis for wear during normal consultations.
►Conduct annual safety inspections.
8.1 Changing the battery
>Required tools and materials:
Flat screwdriver, 710H10=2x3 adjustment wrench
> The patient has taken off the prosthesis.
1) Open the cover at the front of the prosthetic knee joint (see fig.2).
2) Remove the 2 screws used to fasten the battery in the battery compartment (see fig.2).
3) At the notch on the top left side, pry the old battery out of the battery compartment (see fig.3).
4) Insert the new battery into the battery compartment, pressing it in carefully so the contacts do
not bend out of shape (see fig.3).

16
5) Use the 2 enclosed screws to fasten the battery into the battery compartment (see fig.4).
→A signal tone will be emitted after the battery is inserted.
6) Close the cover on the prosthetic knee joint.
9 Disposal
In some jurisdictions it is not permissible to dispose of these products with unsorted
household waste. Disposal that is not in accordance with the regulations of your country
may have a detrimental impact on health and the environment. Please observe the
instructions of your national authority pertaining to return and collection.
10 Legal information
All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
10.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descrip
tions 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.
10.2 Trademarks
All product names mentioned in this document are subject without restriction to the respective
applicable trademark 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 justi
fy the conclusion that the denotation in question is free of third-party rights.
10.3 CE conformity
This product meets the requirements of the European Directive 93/42/EEC for medical devices.
This product has been classified as a class I device according to the classification criteria out
lined in Annex IX of the directive. The declaration of conformity was therefore created by the man
ufacturer with sole responsibility according to Annex VII of the directive.
11 Technical data
Reference number 3E80
Weight [g] 1280
Proximal system height up to the alignment reference point
[mm]
25
Min. distal system height [mm] 228 [2R58, 2R77]
Proximal connection Pyramid adapter
Distal connection Tube clamp Ø 34 mm
Max. flexion angle [°] 140
Max. body weight [kg] 125
Mobility grade 3 to 4
Operating and storage temperature [°C] -10 to 60
Battery charger operating voltage [V] 100 to 240
Battery charger operating frequency [Hz] 50 to 60
Battery charging temperature [°C] 0 to 40

17
1 Descrizione del prodotto Italiano
INFORMAZIONE
Data dell'ultimo aggiornamento: 2020-01-16
►Leggere attentamente il presente documento prima di utilizzare il prodotto.
►Attenersi alle indicazioni di sicurezza per evitare lesioni e danni al prodotto.
►Istruire l'utente sull'utilizzo corretto e sicuro del prodotto.
►Conservare il presente documento.
1.1 Costruzione e funzionamento
Il ginocchio protesico 3E80 è un'articolazione di ginocchio con comando idraulico della rotazione
e modalità di sicurezza a comando elettronico della fase statica. Un microprocessore analizza i
segnali dei sensori incorporati nel ginocchio protesico e comanda l'idraulica.
L'unità di comando elettronica si adegua automaticamente all'utente e non deve essere regolata
dal tecnico ortopedico. L'ammortizzazione della flessione, dell'estensione e della fase statica so
no regolabili individualmente. Questo consente al paziente un'andatura confortevole a diverse ve
locità e un'andatura a passo alternato su superfici in pendenza, superfici irregolari e scendendo
le scale. Il ginocchio protesico dispone anche di una modalità Bicicletta. Se la batteria è scarica
o in caso di guasti, il ginocchio protesico commuta in una modalità di sicurezza con un alto grado
di resistenza alla flessione.
1.2 Possibilità di combinazione
Questo componente protesico è compatibile con il sistema modulare Ottobock. Non è stata testa
ta la funzionalità con componenti di altri produttori che dispongono di elementi di collegamento
modulari compatibili.
Limitazione delle possibilità di combinazione per componenti Ottobock
Denominazione Codice
Piedi protesici 1D35, 1C30, 1C40, 1C50, 1E56, 1E57, 1C60,
1C61, 1C62, 1C63, 1C64
Tubo modulare 2R58, 2R77
Adattatore per invasatura (esempi) 4R41, 4R51, 4R55, 4R111, 4R119
Rivestimento in espanso 3S107
2 Uso conforme
2.1 Uso previsto
Il prodotto deve essere utilizzato esclusivamente per la protesizzazione di arto inferiore.
Il prodotto è indicato solo per il trattamento protesico a seguito di amputazione transfemorale e
disarticolazione di ginocchio.
2.2 Campo d'impiego
I nostri componenti funzionano in modo ottimale se sono combinati con componenti adeguati, se
lezionati in base al peso corporeo e al grado di mobilità, identificabili con il nostro sistema di clas
sificazione MOBIS, e sono dotati di elementi di collegamento modulari adeguati.
°
kg
Il prodotto è consigliato per il grado di mobilità3 (pazienti con capacità motorie il
limitate in ambienti esterni) e per il grado di mobilità4 (pazienti con capacità moto
rie illimitate in ambienti esterni con esigenze particolarmente elevate). Omologato
per pazienti con peso corporeo fino a max.125kg.

18
2.3 Condizioni ambientali
Condizioni ambientali consentite
Intervallo di temperatura: -10°C - +60°C
Umidità dell'aria: 15% - 93%, senza condensa
Pressione atmosferica: 700hPa - 1060hPa
Intervallo temperatura di trasporto e immagazzinamento: -25 °C - +65 °C
Umidità: acqua dolce, sotto forma di spruzzi d'acqua
Condizioni ambientali non consentite
Vibrazioni meccaniche o urti
Sudore, urina, acqua salmastra, acidi
Sabbia, particelle molto igroscopiche (p.es. talco)
2.4 Durata di utilizzo
Questo componente della protesi è stato sottoposto dal produttore a tremilioni di cicli di carico,
in conformità alla norma ISO10328. Ciò corrisponde, a seconda del livello di attività del paziente,
ad un periodo di utilizzo che va da3 a 5anni.
3 Sicurezza
3.1 Significato dei simboli utilizzati
AVVERTENZA Avvertenza relativa a possibili gravi pericoli di incidente e lesioni.
CAUTELA Avvertenza relativa a possibili pericoli di incidente e lesioni.
AVVISO Avvertenza relativa a possibili guasti tecnici.
3.2 Indicazioni generali per la sicurezza
AVVERTENZA
Guida di autoveicoli
Pericolo di incidente dovuto a limitazione dei movimenti del corpo
►Osservare sempre le norme di legge e di carattere assicurativo relative alla conduzione di
autoveicoli e far accertare la propria idoneità alla guida dalle autorità competenti.
CAUTELA
Sollecitazione eccessiva del prodotto
Pericolo di lesioni per rottura di componenti portanti
►Utilizzare i componenti della protesi in base alla classificazione MOBIS.
CAUTELA
Combinazione non consentita di componenti della protesi
Pericolo di lesione per rottura o deformazione del prodotto
►Combinare il prodotto solo con i componenti protesici appositamente omologati.
►Controllare anche, in base alle istruzioni per l’uso dei componenti protesici, se possono es
sere combinati tra di loro.

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CAUTELA
Utilizzo in condizioni ambientali non consentite
Pericolo di lesione per danni al prodotto
►Non esporre il prodotto a condizioni ambientali non consentite.
►Se il prodotto è stato sottoposto a condizioni ambientali non consentite, controllare se è
danneggiato.
►Non continuare a utilizzare il prodotto in presenza di danni evidenti o in caso di dubbio.
►Se necessario, prendere provvedimenti adeguati (p.es. pulizia, riparazione, sostituzione,
controllo da parte del produttore o di un'officina specializzata, ecc.).
CAUTELA
Danno meccanico del prodotto
Pericolo di lesione per cambiamento o perdita di funzionalità
►Trattare con cura il prodotto durante il lavoro.
►In caso di prodotto danneggiato controllarne il funzionamento e le possibilità di utilizzo.
►Non utilizzare più il prodotto in caso di cambiamento o perdita di funzionalità (vedere "Segni
di cambiamento o perdita di funzionalità durante l'utilizzo" in questo capitolo).
►Se necessario, prendere provvedimenti adeguati (p. es. riparazione, sostituzione, controllo
da parte del servizio assistenza al cliente del produttore, ecc.).
CAUTELA
Superamento della durata di utilizzo e utilizzo su un altro paziente
Pericolo di lesione per perdita di funzionalità o danni al prodotto
►Assicurarsi di non superare la durata di utilizzo certificata del prodotto.
►Utilizzare il prodotto solo su un paziente.
CAUTELA
Pericolo di rimanere incastrati nel meccanismo dell'articolazione
Pericolo di rimanere incastrati con parti del corpo (ad es. con le dita) e con la pelle dovuto a
movimento incontrollato dell'articolazione
►Non toccare il meccanismo dell'articolazione durante l'uso quotidiano.
►Eseguire sempre il montaggio e i lavori di regolazione prestando estrema attenzione.
AVVISO
Sovraccarico meccanico
Limitazioni funzionali dovute a danno meccanico
►Prima di ogni utilizzo, verificare che il prodotto non presenti danni.
►Non utilizzare più il prodotto in caso di limitazioni funzionali.
►Se necessario, prendere provvedimenti adeguati (ades. riparazione, sostituzione, controllo
da parte del servizio assistenza al cliente del produttore, ecc.).
Segni di cambiamento o perdita di funzionalità durante l'utilizzo
Segni di cambiamento di funzionalità possono essere, ad esempio, difficoltà motoria, estensione
incompleta, controllo insufficiente nella fase dinamica e minore sicurezza nella fase statica, gene
razione di rumori, ecc.

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4 Fornitura
Fig. Pos. Quantità Denominazione Codice
– – 1 Istruzioni per l’uso –
1 1 1 Ginocchio protesico –
1 2 1 Alimentatore universale 757L16*
1 3 1 Caribatteria 4G497
1 4 1 Chiave di registrazione 710H10=2x3
Kit componenti singoli, composto da: 4G520
5 1 Batteria agli ioni di litio –1
6 4 Viti di fissaggio batteria 501S84=M3x8
Kit componenti singoli, composto da: 4G513=SET
1 7 3 Inserto frontale –
5 Preparazione all'uso
CAUTELA
Allineamento, montaggio o regolazione non corretti
Pericolo di lesione per cambiamento o perdita di funzionalità
►Tutti i lavori di montaggio, regolazione e manutenzione devono essere effettuati esclusiva
mente da personale specializzato.
►Osservare le indicazioni per l'allineamento, il montaggio e la regolazione.
CAUTELA
Utilizzo di talco
Pericolo di lesioni e pericolo di danno al prodotto dovuti alla diminuzione del lubrificante
►Non utilizzare talco sul prodotto o su altri componenti protesici.
CAUTELA
Montaggio errato del tubo
Pericolo di lesione per rottura di componenti portanti
►Durante il montaggio inserire il tubo completamente, fino alla battuta, nel relativo componen
te della protesi.
5.1 Carica della batteria
CAUTELA
Collegamento del caricabatteria senza batteria inserita
Caduta dovuta a ripristino automatico delle impostazioni di fabbrica del ginocchio protesico
►Collegare il caricabatteria al ginocchio protesico solo se la batteria è inserita.
CAUTELA
Non utilizzare la protesi durante il processo di carica
Caduta dovuta a cavo di carica collegato
►Rimuovere la protesi prima di eseguire il processo di carica.
►Prima di indossarla separare la protesi dal caricabatteria.