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
3
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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
16
5

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

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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.

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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 –

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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.