Otto Bock 1B1-2 Meridium User manual

1B1-2=* Meridium
Instructions for use (qualified personnel) ................................................................. 4

DE | INFORMATION
Zusätzlich zu der gedruckten Gebrauchsanweisung, sind auch weitere Sprachen auf CD beigelegt (siehe rückseitigen Um
schlag). Auf Anfrage können Sie eine gedruckte Gebrauchsanweisung kostenlos in der jeweiligen Landessprache unter der un
ten angegebenen Anschrift bestellen.
EN | INFORMATION
In addition to the printed Instructions for Use, additional language versions are also included on CD (see back cover). You can
order a printed version of the Instructions for Use at no charge in the respective national language at the address below.
FR | INFORMATION
Le mode d‘emploi est disponible en d‘autres langues sur CD en supplément de la version imprimée (voir au dos de la couver
ture). Vous pouvez commander gratuitement une version imprimée du mode d‘emploi dans la langue de votre choix en envoyant
votre demande à l‘adresse indiquée ci-dessous.
ES | INFORMAĆION
Aparte de las instrucciones de uso impresas, se incluye un CD con dichas instrucciones en otros idiomas (véase la solapa del
dorso). Puede solicitar de forma gratuita unas instrucciones de uso impresas en el idioma de su país a la dirección que se indi
ca más abajo.
IT | INFORMAZIONE
In aggiunta alle istruzioni per l‘uso in formato cartaceo, il CD contiene le istruzioni anche in altre lingue (vedere il retro della co
pertina). Su richiesta, potete ordinare gratuitamente le istruzioni per l‘uso in formato cartaceo nella relativa lingua del vostro
Paese all‘indirizzo di seguito riportato.
PT | INFORMAÇÃO
Adicionalmente ao manual de utilização impresso encontra-se incluído um CD com mais idiomas (consultar a contracapa). A
pedido é possível encomendar gratuitamente um exemplar impresso do manual de utilização no respectivo idioma junto do
endereço especificado.
NL | INFORMATIE
De gebruiksaanwijzing is behalve in gedrukte vorm ook in diverse andere talen bijgevoegd op cd (zie de achterzijde van de oms
lag). Een gedrukte gebruiksaanwijzing in de gewenste taal kunt u kosteloos bestellen op het hieronder vermelde adres.
SE | INFORMATION
Som komplement till den tryckta bruksanvisningen har dessutom ytterligare språk bifogats på CD (se baksidan av omslaget).
Vid efterfrågan kan du utan kostnad beställa en tryckt bruksanvisning i det respektive språket under den angivna adressen.
DA | INFORMATION
Supplerende til brugsanvisningen på papir er der også vedlagt yderligere sprog på cd (se bagsiden af omslaget). På den oplys
te adresse nedenfor kan du bestille en gratis brugsanvisning på papir på det pågældende sprog.
NO | INFORMASJOU
I tillegg til den trykte bruksanvisningen er flere språk vedlagt på CD (se på baksiden omslaget). Ved forespørsel kan du bestille
en gratis trykt bruksanvisning i det gjeldende språket via adressen nedenfor.
FI | TIEDOT
Painetun käyttöohjeen lisäksi tarjoaa oheinen CD-levy käyttöön myös lisää kieliä (katso kansilehden takapuoli). Painettu käyt
töohje kunkin maan omalla kielellä on pyynnöstä tilattavissa maksutta alla ilmoitetusta osoitteesta.
CZ | INFORMACE
Kromě této vytištěné verze návodu k použití jsou na přiloženém CD k dispozici také další jazykové verze překladu (viz zadní stra
na obalu). V případě požadavku si můžete na níže uvedené adrese zdarma objednat vytištěný návod k použití v příslušném jazy
ce.
PL | INFORMACJA
Dodatkowo do wydrukowanej instrukcji użytkowania dołączono na CD wersję w innych językach (patrz tył okładki). Na żądanie
istnieje możliwość zamówienia bezpłatnie pod podanym poniżej adresem wydrukowanej instrukcji użytkowania w języku danego
kraju.
SK | INFORMÁCIA
Dodatočne ku vytlačenému návodu na používanie sú na CD uložené aj ďalšie jazyky (pozri zadnú obálku). Na požiadanie si
môžete bezplatne objednať vytlačený návod na používanie v príslušnom jazyku krajiny na dole uvedenej adrese.
HU | INFORMATION
A kinyomtatott használati utasítást kiegészíti a további nyelveket tartalmazó, mellékelt CD (ld. a hátlapon lévő borítékot). Az
alábbi címen, kérésre költségmentesen megrendelhet az adott ország nyelvén kinyomtatott használati utasítást.
HR | INFORMACIJA
Dodatno uz tiskane upute za uporabu priloženi su i drugi jezici na CD-u (vidi poleđinu). Na upit možete na dolje navedenoj adre
si besplatno naručiti tiskane upute za uporabu na dotičnom jeziku.
2 1B1-2=* Meridium

TR | INFORMATION
Basılmış olan kullanım kılavuzuna ilave olarak CD'de daha fazla alternatif diller bulunmaktadır (bakınız zarfın arka yüzü). İstek
üzerine ilgili dilde basılmış kullanım kılavuzunu aşağıda belirtilmiş olan adresten temin edebilirsiniz.
Ottobock Healthcare Products GmbH
Brehmstraße 16 | 1110 Wien | Austria
[email protected] | Fax [phone]
31B1-2=* Meridium

1 Foreword English
INFORMATION
Date of last update: 2019-07-26
►Please read this document carefully before using the product.
►Instruct the user in the proper and safe use of the product.
►Please contact the manufacturer if you have questions about the product (e.g.regarding the start-up, use,
maintenance, unexpected operating behaviour or circumstances). Contact information can be found on the
back page.
►Please keep this document in a safe place.
The product "1B1-2=* Meridium" is referred to as the product/component/prosthesis/prosthetic foot below.
These instructions for use provide you with important information on the use, adaptation and handling of the
product.
Only put the product into use in accordance with the information contained in the accompanying documents sup
plied.
2 Product description
2.1 Design
The product consists of the following components:
1. Cover/connection plate
2. Cover cap with charging receptacle
3. Battery
4. Ankle spring
5. Heel bracket
6. Ankle axis
7. Heel spring
8. Hydraulic unit
9. Toe axis
10. Toe plate
11. Carbon fibre frame
12. Main electronics
2.2 Function
This product features microprocessor-controlled damping of plantar flexion (motion of the foot in the ankle joint in
the direction of the sole of the foot) and dorsiflexion (motion of the foot in the ankle joint in the direction of the
instep).
The microprocessor uses the measurements of an integrated sensor system as a basis to control a hydraulic unit
that influences the damping behaviour of the product.
These sensor data are updated and evaluated 100 times per second. As a result, the behaviour of the product is
adapted to the current motion situation (gait phase) dynamically and in real time.
Thanks to the microprocessor-controlled damping of the plantar flexion and dorsiflexion, the product can be indi
vidually adapted to the needs of the patient.
For this purpose, the product is configured with the "M-Soft" adjustment software.
The product features MyModes for special motion types (e.g. golf ...). These have default values configured using
the adjustment software and can be accessed via the Cockpit app or using a special motion pattern (see Page24).
Additionally, provided it is configured using the adjustment software, a so-called lock mode (additional mode
"Ankle lock") can also be selected, locking the ankle joint of the prosthetic foot in its current position.
4 1B1-2=* Meridium
Foreword

In case of a product malfunction, safety mode makes restricted operation possible. Resistance parameters that are
predefined by the product are configured for this purpose (see Page29).
Empty battery mode permits safe walking when the battery is drained. Resistance parameters that are predefined
by the product are configured for this purpose (see Page29).
The microprocessor-controlled hydraulic unit offers the following advantages
• Approximation of the physiological gait pattern
• Stable standing on even and inclined surfaces
• Adaptation of product characteristics to various surfaces, inclines, gait situations, walking speeds and heel
heights
2.3 Combination possibilities
This product can be combined with the following Ottobock components:
Knee joints
• Genium: 3B1, 3B1=ST, 3B1-2, 3B1-2=ST, 3B1-3, 3B1-3=ST
• Genium X3: 3B5-X3, 3B5-X3=ST, 3B5-2, 3B5-2=ST, 3B5-3, 3B5-3=ST
• 3C98-2, 3C88-2 C-Leg knee joint
• 3C98-3, 3C88-3 C-Leg
Cosmetic cover/protector
• 4X860=* C-Leg Protective Cover (w/o shield)
• 4X880=* Genium Protective Cover
• 3S26 cosmetic foam cover
Footshells
• Translucent: 2C7=[prosthesis side][foot size]/1
• Beige: 2C7=[prosthesis side][foot size]/4
• Brown: 2C7=[prosthesis side][foot size]/15
[prosthesis side]: L=left, R=right
[foot size]: 24, 25, 26, 27, 28, 29
Order example: Footshell for left prosthetic foot in foot size 25 and beige colour
Article number: 2C7=L25/4
3 Intended use
3.1 Indications for use
The product is to be used solely for lower limb exoprosthetic fittings.
3.2 Conditions of use
The product was developed for everyday use and must not be used for unusual activities. These unusual activities
include, for example, sports with excessive impact load (tennis, basketball, running, ...) or extreme sports (free
climbing, paragliding, etc.).
Permissible ambient conditions are described in the technical data (see Page32).
The product is intended exclusively for use on one patient. Use of the product by another person is not approved
by the manufacturer.
Our components perform optimally when paired with appropriate components based upon weight and mobility
grades identifiable by our MOBIS classification information and which have appropriate modular connectors.
°
kg
The product is recommended for mobility grade2 (restricted outdoor walker) and mobility
grade3 (unrestricted outdoor walker).
Foot size [cm] 24 to 25 26 to 29
Max. body weight [kg] 100 125
51B1-2=* Meridium
Intended use

3.3 Service life
1B1-2 Meridium
This product has been tested by the manufacturer with 2 million load cycles according to ISO 22675. Depending
on the patient's activity level, this corresponds to a service life of 2 to 3 years.
The service life can be individually extended depending on the intensity of use by making use of regular service
inspections.
2C7=* footshell
The product has a service life of one year when professionally installed and properly used. Damaged footshells
must be replaced immediately, before the prosthetic foot is used again.
4G872=* cover cap set, 2C101 footshell replacement tool
These products are wear and tear parts, and therefore subject to natural wear. The service life diminishes or
increases depending on the individual level of use. The maximum service life – which depends on the level of use –
can only be achieved when the instructions for use are observed.
3.4 Indications
• For users with unilateral knee disarticulation and unilateral transfemoral amputation
• For users with unilateral or bilateral transtibial amputation
• The user must fulfil the physical and mental requirements for perceiving optical/acoustic signals and/or mech
anical vibrations
3.5 Qualification
The product may be fitted only by qualified personnel authorised by Ottobock after completing the corresponding
training.
4 Safety
4.1 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.
4.2 Structure of the safety instructions
WARNING
The heading describes the source and/or the type of hazard
The introduction describes the consequences in case of failure to observe the safety instructions. Consequences
are presented as follows if more than one consequence is possible:
> E.g.: Consequence 1 in the event of failure to observe the hazard
> E.g.: Consequence 2 in the event of failure to observe the hazard
►This symbol identifies activities/actions that must be observed/carried out in order to avert the hazard.
4.3 General safety instructions
WARNING
Use of damaged power supply unit, adapter plug or battery charger
Risk of electric shock due to contact with exposed, live components.
►Do not open the power supply unit, adapter plug or battery charger.
►Do not expose the power supply unit, adapter plug or battery charger to extreme loading conditions.
►Immediately replace damaged power supply units, adapter plugs or battery chargers.
CAUTION
Failure to observe warnings/error signals
Falling due to unexpected behaviour of the prosthesis because of changed damping behaviour.
►Observe the warnings/error signals and corresponding change in damping settings.
6
Safety
1B1-2=* Meridium

CAUTION
Independent manipulation of the product and the components
Falling due to breakage of load-bearing components or malfunction of the product.
►Manipulations to the product other than the tasks described in these instructions for use are not permitted.
►The battery may only be handled by authorised, qualified Ottobock personnel (no replacement by the user).
►The product and any damaged components may only be opened and repaired by authorised, qualified
Ottobock personnel.
CAUTION
Mechanical stress on the product
> Falling due to unexpected product behaviour as the result of a malfunction.
> Falling due to breakage of load-bearing components.
> Skin irritation due to defects on the hydraulic unit with leakage of liquid.
►Do not subject the product to mechanical vibrations or impacts.
►Check the product for visible damage before each use.
CAUTION
Use of the product when battery charge level is too low
Falling due to unexpected behaviour of the prosthesis because of changed damping behaviour.
►Check the current charge level before use and charge the prosthesis if required.
►Note that the operating time of the product may be reduced at low ambient temperatures or due to ageing of
the battery.
CAUTION
Penetration of liquid into system components
Falling due to unexpected product behaviour as the result of malfunction.
►When the footshell is intact, the prosthesis is protected against splashed water from all directions. However, it
is not protected against submersion, jets of water and steam.
►If water has penetrated system components, remove the footshell and allow the components to dry. The pros
thesis must be inspected by an authorised Ottobock Service Centre.
►If salt water has penetrated the prosthesis, the footshell must be removed immediately. The prosthesis must
be inspected by an authorised Ottobock Service Centre.
►Do not use the product for bathing prostheses.
CAUTION
Overloading due to unusual activities
> Falling due to unexpected product behaviour as the result of malfunction.
> Falling due to breakage of load-bearing components.
> Skin irritation due to defects on the hydraulic unit with leakage of liquid.
►The product was developed for everyday use and must not be used for unusual activities. These unusual activ
ities include, for example, sports with excessive impact load (tennis, basketball, running, ...) or extreme sports
(free climbing, paragliding, etc.).
►Careful handling of the product and its components not only increases their service life but, above all, ensures
the patient's personal safety!
►If the product and its components have been subjected to extreme loads (e.g. due to a fall, etc.), then the
product must be inspected for damage immediately. If necessary, forward the product to an authorised
Ottobock Service Centre.
CAUTION
Mechanical stress during transport
> Falling due to unexpected product behaviour as a result of a malfunction.
> Falling due to breakage of load-bearing components.
> Skin irritation due to defects on the hydraulic unit with leakage of liquid.
►Only use the transport packaging for transportation.
71B1-2=* Meridium
Safety

CAUTION
Signs of wear and tear on the product components
Falling due to damage or malfunction of the product.
►Regular service inspections (maintenance) are mandatory in the interest of patient safety and in order to main
tain operating reliability and protect the warranty.
NOTICE
Improper product care
Damage to the product due to the use of incorrect cleaning agents.
►Only clean the product with a damp cloth and mild soap (e.g. 453H10=1 Ottobock DermaClean).
NOTICE
Mechanical damage to the product
Change in or loss of functionality due to damage.
►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.).
INFORMATION
When exoprosthetic components are used, the use of control functions which are performed hydraulically or
movement of the component in the footshell can cause movement noise. This kind of noise is normal and unavoid
able. It generally does not cause any problems. If movement noise increases noticeably during the lifecycle of the
component, the component should be inspected by an authorised Ottobock Service Centre immediately.
Signs of changes in or loss of functionality during use
Decreased forefoot resistance or changes in roll-over behaviour are noticeable indications of loss of functionality.
4.4 Information on the Power Supply/Battery Charging
CAUTION
Charging the prosthesis without taking it off
> Falling due to walking and getting caught on the connected battery charger.
> Falling due to unexpected behaviour of the prosthesis because of changed damping behaviour.
►Instruct the patient that the prosthesis must be taken off before it is charged.
CAUTION
Charging the product with damaged power supply unit/charger/charger cable
Falling due to unexpected behaviour of the product caused by insufficient charging.
►Check the power supply unit, charger and charger cable for damage before use.
►Replace any damaged power supply unit, charger or charger cable.
NOTICE
Use of incorrect power supply unit/battery charger
Damage to product due to incorrect voltage, current or polarity.
►Use only power supply units/battery chargers approved for this product by Ottobock (see instructions for use
and catalogues).
8
Safety
1B1-2=* Meridium

4.5 Battery charger information
NOTICE
Penetration of dirt and humidity into the product
Lack of proper charging functionality due to malfunction.
►Ensure that neither solid particles nor liquids can penetrate into the product.
NOTICE
Mechanical stress on the power supply/battery charger
Lack of proper charging functionality due to malfunction.
►Do not subject the power supply/battery charger to mechanical vibrations or impacts.
►Check the power supply/battery charger for visible damage before each use.
NOTICE
Operating the power supply unit/charger outside of the permissible temperature range
Lack of proper charging functionality due to malfunction.
►Only use the power supply unit/charger for charging within the allowable temperature range. The section
"Technical data" contains information on the allowable temperature range (see Page32).
NOTICE
Independent changes or modifications carried out to the battery charger
Lack of proper charging functionality due to malfunction.
►Have any changes or modifications carried out only by Ottobock authorised, qualified personnel.
4.6 Information on Alignment/Adjustment
CAUTION
Use of unsuitable prosthesis components
Falling due to unexpected behaviour of the product or breakage of load-bearing components.
►Use the product only in combination with components listed in the section "Combination possibilities" (see
Page5).
CAUTION
Use of unapproved accessories
> Falling due to product malfunction as a result of reduced resistance to interference.
> Interference of other electronic devices due to increased emissions.
►Use the product only in combination with the accessories, signal converters and cables listed in the sections
"Combination possibilities" (see Page5), "Scope of delivery" (see Page13) and "Accessories" (see
Page13).
CAUTION
Incorrect alignment or assembly
Falling due to damage to the prosthesis components.
►Observe the alignment and assembly instructions.
CAUTION
Disconnecting/establishing the connection during the adjustment process with the adjustment software
Falling due to unexpected behaviour of the product.
►When wearing the product, the patient must not remain unattended during the configuration process while
connected to the adjustment software.
►Observe the maximum range of the Bluetooth connection.
►During the data transfer (PC to product), the patient must stand or sit without moving.
►If the connection fails while making adjustments, the prosthetist must immediately warn and secure the
patient.
►The connection to the product must always be disconnected after adjustments have been completed.
91B1-2=* Meridium
Safety

CAUTION
Operator errors during the adjustment process with the adjustment software
Falling due to unexpected behaviour of the product.
►Participation in an Ottobock product training course is mandatory prior to using the product. Additional
product training courses may become necessary to qualify for software updates.
►Correctly entering the patient data (e.g. body weight) is an important criterion for the quality of the fitting.
►Always enter the weight in the specified unit.
►Ensure that the required dimensions are selected and entered correctly.
►If the patient uses walking aids (e.g. crutches or walking canes) during the adjustment process, readjustment
is required as soon as the patient stops using these walking aids.
4.7 Information on Proximity to Certain Areas
CAUTION
Insufficient distance to HF communication devices (e.g. mobile phones, Bluetooth devices, WiFi
devices)
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
►Therefore, keeping a minimum distance of 30cm to HF communication devices is recommended.
CAUTION
Operating the product in very close proximity to other electronic devices
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
►Do not operate the product in the immediate vicinity of other electronic devices.
►Do not stack the product with other electronic devices during operation.
►If simultaneous operation cannot be avoided, monitor the product and verify proper use in the existing setup.
CAUTION
Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention systems, metal
detectors)
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
►Ensure that the patient is not in the vicinity of sources of strong magnetic and electrical interference during tri
al fitting (such as theft prevention systems, metal detectors...).
If this cannot be avoided, ensure at least that the patient has a safeguard when walking or standing (e.g. a
handrail or the support of another person).
►In general, monitor the product for unexpected changes in the damping behaviour when electronic or magnet
ic devices are in the immediate vicinity.
CAUTION
Remaining in areas outside the allowable temperature range
Falling due to malfunction or the breakage of load-bearing product components.
►Ensure that the patient is not in areas outside the permissible temperature range (see Page32) during trial fit
ting.
4.8 Information on Use
CAUTION
Walking up stairs
Falling due to foot placed incorrectly on stair.
►Ensure that the patient uses the handrail when walking up stairs and places most of the sole of the foot on the
stair surface. The toe plate may fold away if only the front part of the foot is placed on the edge of the stair.
►Inform the patient that particular caution is required when carrying children while walking up stairs.
10
Safety
1B1-2=* Meridium

CAUTION
Walking down stairs
Falling due to foot being placed incorrectly on stair as a result of changed damping behaviour.
►Ensure that the patient uses the handrail when walking down stairs and places most of the sole of the foot on
the stair surface. Rolling the foot over the edge of the stair is not necessary.
►Inform the patient that particular caution is required when carrying children while walking down stairs.
CAUTION
High temperature of the hydraulic unit due to uninterrupted, increased activity (e.g. extended walking
downhill)
Falling due to unexpected behaviour of the product caused by use in overheating mode.
►Be sure to pay attention when pulsating vibration signals start. They indicate the risk of overheating.
►As soon as these pulsating vibration signals begin, you must reduce your level of activity so the hydraulic unit
can cool down.
►Please note that the range of motion in the ankle joint is reduced as the temperature increases, and this may
ultimately result in the ankle joint being locked completely. Special caution is therefore required, especially
when walking down stairs.
►Full activity may be resumed after the pulsating vibration signals stop.
CAUTION
Improper mode switching
Falling due to unexpected behaviour of the product because of changed damping behaviour.
►Ensure that the patient stands securely during all switching processes.
►Inform the patient that the changed damping characteristics have to be verified after switching and feedback
from the acoustic signal emitter must be observed.
►Switching back to basic mode is mandatory once the activities in MyMode have been completed.
►If required, take the weight off the product and correct the switching.
CAUTION
Using prosthetic foot without footshell
Falling due to slipping when walking on smooth floor surfaces (tiles).
►Do not use the prosthetic foot without the accompanying footshell.
CAUTION
Using prosthetic foot with a damaged foot shell
> Falling due to unexpected product behaviour as the result of malfunction.
> Falling due to breakage of load-bearing components.
►Do not use the prosthetic foot when the foot shell is damaged. Replace damaged foot shells immediately,
before using the product again.
4.9 Notes on the safety modes
CAUTION
Using the product in safety mode
Falling due to unexpected product behaviour because of changed damping behaviour.
►The warnings/error signals (see Page34) have to be observed.
CAUTION
Safety mode cannot be activated due to malfunction caused by water penetration or mechanical damage
Falling due to unexpected product behaviour because of changed damping behaviour.
►Using the product when it is defective is prohibited.
►The product must be inspected by an authorised Ottobock Service Centre.
111B1-2=* Meridium
Safety

CAUTION
Safety mode cannot be deactivated
Falling due to unexpected product behaviour because of changed damping behaviour.
►If safety mode cannot be deactivated by recharging the battery, a permanent error has occurred.
►Using the product when it is defective is prohibited.
►The product must be inspected by an authorised Ottobock Service Centre.
CAUTION
Safety signal occurs (ongoing vibration)
Falling due to unexpected product behaviour because of changed damping behaviour.
►The warnings/error signals (see Page34) have to be observed.
►After the safety signal has been emitted, further use of the product is prohibited.
►The product must be inspected by an authorised Ottobock Service Centre.
4.10 Information on the use of a mobile device with the cockpit app
CAUTION
Improper use of the mobile device
Falling due to altered damping behaviour as a result of unexpected switching into a MyMode.
►Use the instructions for use (user) to instruct the patient on the proper handling of the mobile device with the
Cockpit app.
CAUTION
Independently applied changes or modifications made to the mobile device
Falling due to altered damping behaviour as a result of unexpected switching to a MyMode.
►Do not make any independent changes to the hardware of the mobile device on which the app is installed.
►Do not make any independent changes to the software/firmware of the mobile device that are not included in
the update function of the software/firmware.
CAUTION
Improper mode switching with the mobile device
Falling due to unexpected product behaviour because of changed damping behaviour.
►Ensure that the patient stands securely during all switching processes.
►Inform the patient that the changed damping characteristics have to be verified after switching, and feedback
from the acoustic signal emitter and the mobile device display must be observed.
►Switching back to basic mode is mandatory once the activities in the MyMode have been completed.
NOTICE
Destruction of the device due to falling or penetration of water
Malfunction of the device.
►If necessary, let the device dry at room temperature (at least 1 day).
►If it should no longer be possible to switch back from a MyMode to basic mode, the component can only be
switched back to basic mode by using a movement pattern (see Page26) or by connecting/disconnecting the
battery charger.
NOTICE
Failure to observe the system requirements for the installation of the Cockpit app
Malfunction of the mobile device.
►Install the Cockpit app only on the operating systems listed in the section "System requirements" (see
Page17).
12
Safety
1B1-2=* Meridium

5 Scope of Delivery and Accessories
5.1 Scope of delivery
• 1pc. 1B1-2 Meridium
• 1pc. 757L16-4 power supply
• 1 pc. 4E50-2 C-Leg battery charger
• 1pc. 646C107 Bluetooth PIN card
• 1 pc. 647F542 prosthesis passport
• 1pc. 647G1440=1 instructions for use (user)
• 1pc. 647G1440=2 instructions for use (user)
• 1pc. 647G1441 instructions for use (qualified personnel)
• 1 pc. 2C7 footshell inc. instructions for use
• 1pc. 4G872=* set of cover caps
• 1 pc. 2C101 footshell replacement tool
Cockpit app for download from the website:
http://www.ottobock.com/cockpitapp
• “Cockpit 4X441-IOS=V*” app for iOS
• “Cockpit 4X441-ANDR=V*” app for Android
5.2 Accessories
The following components are not included in the scope of delivery and may be ordered separately:
• 60X5 BionicLink PC
• 1 pc. 757P48 Y adapter cable
This is for charging more than one product at the same time (e.g. 1B1-2; 1B1; 3B1/3B1=ST; 3B1-2/3B1-2=ST;
3B5-X3/3B5-X3=ST; 3C98-2/3C88-2; 3C98-3/3C88-3; 3C96-1/3C86-1) with the 757L16-4 power supply.
• 704G30 clamping tool
6 Charging the battery
The following points must be observed when charging the battery:
• Use the 757L16-4 power supply and 4E50-2 battery charger to charge the battery.
• The capacity of a fully charged battery is sufficient for one full day.
• We recommend charging the product once a day when used by the patient on a daily basis.
• For the maximum operating time with one battery charge, disconnecting the battery charger from the product
only immediately before using the product is recommended.
• The battery should be charged until the yellow LED on the battery charger turns off prior to initial use, and for
at least 4 hours. This calibrates the charge level indicator via the Cockpit app and by turning over the prosthes
is.
If the battery charger is disconnected from the prosthesis too soon, the charge level indicator via the Cockpit
app and by turning over the prosthesis may not correspond to the actual charge level.
• The ankle joint of the prosthetic foot is locked during the charging process.
• The battery may discharge while the product is not being used.
6.1 Connecting the power supply and battery charger
1 2 3
1) Slide the country-specific plug adapter onto the power supply until it locks into place (see fig.1).
2) Connect the round, four-pin plug of the charging cable to the OUT receptacle on the battery charger so that
the plug locks into place (see fig.2).
INFORMATION: Ensure correct polarity (guide lug). Do not use force when connecting the cable plug
to the battery charger.
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Scope of Delivery and Accessories

3) Connect the round, three-pin plug of the power supply to the 12V receptacle on the battery charger so that
the plug locks into place (see fig.2).
INFORMATION: Ensure correct polarity (guide lug). Do not use force when connecting the cable plug
to the battery charger.
4) Plug the power supply unit into the wall socket.
→The green LED on the back of the power supply and the green LED on the battery charger light up (see
fig.3).
→If the green LED on the power supply and the green LED on the battery charger do not light up, there is an
error (see Page34).
6.2 Charging the prosthesis battery
1) Open the charging receptacle cover.
2) Connect the charging plug to the charging receptacle of the product.
INFORMATION: Take note of the plug direction!
→The correct connection of the battery charger to the product is indicated by
feedback (see Page36).
3) The charging process starts.
→Once the product battery is fully charged, the yellow LED on the battery
charger turns off.
4) Disconnect the product after the charging process is complete.
→This is followed by an electronics self-test which is confirmed by feedback
(see Page36).
5) Close the charging receptacle cover.
6.3 Display of the current charge level
INFORMATION
The charge level cannot be displayed during the charging process.
1) Turn the prosthesis by 180° (the sole of the foot must face up).
2) Hold the prosthesis still and wait for beep signals.
Prosthetic foot with knee joint:
The beep signal for the knee joint sounds after approx. 2seconds.
The beep signal for the prosthetic foot sounds after approx. 4seconds.
Prosthetic foot without knee joint:
The beep signal for the prosthetic foot sounds after approx. 2seconds.
Beep signal Vibration signal Battery charge level
5x short – More than 80%
4x short – 66% to 80%
3x short – 51% to 65%
2x short – 36% to 50%
1x short 3x long 20% to 35%
1x short 5x long Less than 20%
INFORMATION
If the Volume parameter is set to '0' in the Cockpit app, there are no beep signals (see Page26).
Display of the current charge level using the cockpit app:
Once the Cockpit app has been started, the current charge level is displayed in the bottom line of the screen:
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Charging the battery
1B1-2=* Meridium

1. 38% – Charge level of battery for currently connected component
7 Preparation for use
7.1 Applying/removing footshell
For applying/removing the footshell, please consult the instructions for use included with the footshell.
CAUTION
Incorrect assembly/disassembly and improper use of footshell
> Falling due to unexpected product behaviour as the result of malfunction.
> Falling due to breakage of load-bearing components.
►Use the prosthetic foot only in combination with the footshell.
►Remove the footshell from the prosthetic foot only when necessary.
►Only use the 2C101 changing device and the 704G30 clamping device for mounting/removing.
►Replace worn footshells. Do not use the prosthetic foot when the footshell is damaged.
INFORMATION
Before mounting the component on the tube adapter, make a note of the serial number of the component. It is
found next to the pyramid on the spherical cap.
The serial number is required to connect to the adjustment software and the Cockpit app, and must be entered in
the prosthesis passport.
7.2 Alignment
7.2.1 Bench alignment in alignment apparatus
With correct bench alignment, e.g. in the PROS.A. assembly alignment apparatus (743A200), the benefits of the
product are realised to best advantage. If the L.A.S.A.R. assembly alignment apparatus (743L200) is available, it
can be used as well.
Alignment can also be carried out using LaserLine/plumb line.
The following points must be observed during alignment:
• The alignment recommendations provided must be observed in order for the prosthetic foot to function cor
rectly.
• Static alignment in the alignment apparatus must always be carried out without shoes, otherwise a correct
adjustment will not be possible.
• A marking is located on the exterior distal side of the footshell. The marking serves as orientation for the align
ment point on the foot.
• Before beginning the alignment, the prosthetic foot must be put into alignment mode using the adjustment soft
ware ("Alignment" tab, "Alignment Recommendation" tab). Only in alignment mode will the prosthetic foot be
locked in neutral position and allow static alignment to be carried out correctly.
Foot size (cm) Mid-foot anterior to the alignment
reference line
Heel height
24–29 30mm 0mm
Bench alignment for transtibial (TT) modular lower limb prostheses
The adjustment software must be used to provide information for alignment of TT modular lower limb prostheses
(also see TT modular lower limb prostheses: 646F336).
Bench alignment for transfemoral (TF) modular lower limb prostheses
The alignment recommendations for the appropriate Ottobock knee joint must be observed for TF modular lower
limb prostheses (also see TF modular prostheses: 646F219).
7.2.2 Static alignment optimisation
• Use the L.A.S.A.R. Posture for static alignment optimisation of the prosthesis, if available.
151B1-2=* Meridium
Preparation for use

• Use the alignment recommendations of the manufacturer (TF modular lower limb prostheses: 646F219,TT
modular lower limb prostheses: 646F336).
7.2.3 Dynamic alignment optimisation
Make sure the heel height is correctly set before beginning the dynamic alignment optimisation!
• Dynamic alignment optimisation is not necessary if the static situation is satisfactory. The adjustment software
is used to make adjustments to ensure correct heel contact, smooth rollover and optimum weight transfer on
the contralateral side.
• Adjust the prosthesis in the frontal plane (ML) by using the medial-lateral screws to change its angle or shift it
(see 646F336) so as to minimise any axial run-out in the knee.
7.2.4 Mounting cover plate/connecting plate/cover cap
Depending on the cosmetic that is being used (cosmetic foam cover, Protector), the suitable element must be
selected from the set of cover caps and mounted on the product.
7.2.4.1 Mounting the cover cap
The cover cap forms the top of the footshell.
►Mount the cover cap according to the 647G977 instructions for use.
7.2.4.2 Mounting the cover plate
If the cover plate is being used, there should be no cosmetic (Protector, cos
metic foam cover) on the product.
►Fit the cover plate on the cover cap which has already been mounted.
7.2.4.3 Mounting the Protector connecting plate
The Protective Cover connecting plate acts as the connection between the
prosthetic foot and the Protective Cover.
1) Apply adhesive to the cover cap in 4 places (adhesive areas about 15 mm
long).
2) Fit the Protective Cover connecting plate to the cover cap which has
already been mounted.
3) Fasten the clips of the foot cuff to the connecting plate of the Protective
Cover.
INFORMATION: Please note the 647G1113/647G942 instructions for
use.
7.2.4.4 Mounting the connecting plate for the cosmetic foam cover
The connecting plate for the cosmetic foam cover acts as the connection
between the prosthetic foot and the cosmetic foam cover.
1) Fit the connecting plate for the cosmetic foam cover to the cover cap which
has already been mounted.
2) Trim the cosmetic foam cover to fit the connecting plate for the cosmetic
foam cover.
3) Apply a layer of 636N9 contact adhesive to the contact surfaces of the cos
metic foam cover.
4) Place the cosmetic foam cover on the connecting plate for the cosmetic
foam cover.
16
Preparation for use
1B1-2=* Meridium

8 Cockpit app
The cockpit app enables switching from basic mode into the pre-configured MyModes. In
addition, information about the product (step counter, battery charge level, etc.) can be
called up.
The behaviour of the product can be changed to a certain extent on a day-to-day basis
using the app (e.g. while becoming accustomed to the product). The adjustment software
can be used to trace the change at the patient's next appointment.
INFORMATION
The Cockpit app can be downloaded free of charge from the respective online store. For more information,
please visit the website: http://www.ottobock.com/cockpitapp. To download the Cockpit app, the QR code on the
supplied Bluetooth PIN card can be read with the mobile device (requirement: QR code reader and camera).
INFORMATION
The language of the Cockpit app user interface can only be changed using the adjustment software.
INFORMATION
The serial number of the component to be connected has to be registered with Ottobock the first time it is con
nected. If the registration is not accepted, use of the Cockpit app for this component will be limited.
INFORMATION
Bluetooth on the prosthesis must be turned on in order to use the Cockpit app.
If Bluetooth is switched off, it can be turned on by turning the prosthesis upside-down (sole of the foot must point
up) or by connecting/disconnecting the battery charger. Bluetooth is then turned on for approx. 2 minutes. During
this time, the app must be started and used to establish a connection. If required, Bluetooth on the prosthesis can
be switched on permanently afterwards (see Page28).
8.1 System Requirements
The functioning of the Cockpit app is assured on devices that support the following operating systems:
•iOS (for iPhone, iPad, iPod): version 9.3 or higher. The mobile device has to support Bluetooth 4.0 (BT LE).
•Android: version 4.1 or higher
8.2 Initial connection between cockpit app and prosthesis
The following points should be observed before the initial connection:
• Bluetooth of the component must be switched on (see Page28).
• Bluetooth on the mobile device must be switched on.
• The device must not be in "flight mode" (offline mode), otherwise all wireless connections are turned off.
•The device must be connected to the internet.
• The serial number and Bluetooth PIN of the component being connected must be known. They are found on
the enclosed Bluetooth PIN card. The serial number begins with the letters "SN".
INFORMATION
If the Bluetooth PIN card with the Bluetooth PIN and serial number of the component is lost, the Bluetooth PIN
can be determined using the adjustment software.
8.2.1 Starting the cockpit app for the first time
1) Tap the symbol of the Cockpit app ( ).
→The end user license agreement (EULA) is displayed.
2) Accept the end user license agreement (EULA) by tapping the Accept button. If the end user license agree
ment (EULA) is not accepted, the Cockpit app cannot be used.
→The welcome screen appears.
3) Hold the prosthesis with the sole of the foot facing up, or connect and then disconnect the battery charger, in
order to activate recognition (visibility) of the Bluetooth connection for 2minutes.
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Cockpit app

4) Tap the Add component button.
→The Connection Wizard opens and guides you through the process of establishing a connection.
5) Follow the subsequent instructions on the screen.
6) After the Bluetooth PIN is entered, a connection to the component is established.
→While the connection is being established, 3beep signals sound and the symbol appears.
The symbol is displayed when the connection has been established.
→Once the connection has been established, the data are read from the component. This process may take up to
a minute.
Then the main menu appears with the name of the connected component.
INFORMATION
After the initial connection to the component has been established successfully, the app will connect automatically
each time it is started. No further steps are required.
8.3 Control elements for cockpit app
12345678Product change
2. Golf
1. Basic Mode
1. Basic Mode
100%
1. Access the navigation menu (see Page19)
2. Product
The component name can only be changed with the adjustment soft
ware.
3. If connections to more than one component have been saved, you can
switch between the saved components by tapping the change item (see
Page19).
4. MyModes configured with the adjustment software.
Switch the mode by tapping the corresponding symbol and confirming
by tapping "OK".
5. Currently selected mode
6. Charge level of the component.
Component battery fully charged
Component battery empty
Component battery charging
The current charge level is also displayed in %.
7. Display and name of the currently selected mode (e.g. 1. Basic Mode)
8. Connection to component has been established
Connection to component has been interrupted. The app is attempt
ing to re-establish the connection automatically.
No existing connection to the component.
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Cockpit app
1B1-2=* Meridium

8.3.1 Cockpit app navigation menu
change
2. Golf
Product
MyModes
Functions
Heel Height
Status
General
Manage components
Imprint/Info
Settings
4Tap the symbol in the menus to display the navigation menu. Additional
settings for the connected component can be configured in this menu.
Product
Name of the connected component
MyModes
Return to the main menu to switch MyModes
Heel Height
Setting the heel height (see Page21)
Functions
Access additional functions of the component (e.g. turn off Bluetooth) (see
Page28)
Settings
Change settings of the selected mode (see Page26)
Status
Query status of the connected component (see Page29)
Manage components
Add or delete components (see Page19)
Imprint/Info
Display information/legal notices for the Cockpit app
8.4 Managing components
Connections with up to four different components can be stored in the app. However, a component can only be
connected to one device at a time.
The following points need to be observed before establishing the connection:
• Bluetooth of the component must be switched on (see Page28).
• Bluetooth on the mobile device must be switched on.
• The device must not be in "flight mode" (offline mode), otherwise all wireless connections are turned off.
•The device must be connected to the internet.
• The serial number and Bluetooth PIN of the component being connected must be known. They are found on
the enclosed Bluetooth PIN card. The serial number begins with the letters "SN".
INFORMATION
If the Bluetooth PIN card with the Bluetooth PIN and serial number of the component is lost, the Bluetooth PIN
can be determined using the adjustment software.
8.4.1 Adding component
1) Tap the symbol in the main menu.
→The navigation menu opens.
2) In the navigation menu, tap the "Manage components" item.
3) Hold the prosthesis with the sole of the foot facing up, or connect and then disconnect the battery charger, in
order to activate recognition (visibility) of the Bluetooth connection for 2minutes.
4) Tap the "+" button.
→The Connection Wizard opens and guides you through the process of establishing a connection.
5) Follow the subsequent instructions on the screen.
6) After the Bluetooth PIN is entered, a connection to the component is established.
→While the connection is being established, threebeep signals sound and the symbol appears.
The symbol is displayed when the connection has been established.
→Once the connection has been established, the data are read from the component. This process may take
up to a minute.
The main menu will then appear with the name of the connected component.
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Cockpit app

INFORMATION
If establishing a connection to a component is not possible, perform the following steps:
►Delete the component from the Cockpit app if applicable (see the section "Deleting a component")
►Add the component again in the Cockpit app (see the section "Adding a component")
INFORMATION
After activating the "visibility" of the component (holding the component with the sole of the foot facing up, or con
necting and then disconnecting the battery charger), the component can be recognised by another device
(e.g.smartphone) within 2minutes. If registration or establishing the connection takes too long, the process of
establishing a connection is cancelled. In this case, hold the component with the sole of the foot facing up again,
or connect and then disconnect the battery charger.
8.4.2 Deleting a component
1) Tap the symbol in the main menu.
→The navigation menu opens.
2) In the navigation menu, tap the entry "Manage components".
3) Tap the "Edit" button.
4) Tap the symbol under the component you want to delete.
→The component is deleted.
8.4.3 Connecting component with multiple devices
The connection for a component can be stored on more than one device. However, only one device can be con
nected to the component at one time.
If there is an existing connection between the component and a different device, the following information appears
while the connection is being established with the current device:
Connect to this component?
Cancel OK
Component was connected to
another device.
Establish connection?
►Tap the OK button.
→The connection to the last connected device is broken off and estab
lished with the current device.
9 Use
9.1 Setting the heel height
The heel height of the prosthesis must be set on a level surface. A sloped ground surface distorts the heel height
measurement and leads to improper control of damping behaviour.
A heel height that is too high may cause control of the prosthetic foot to function incorrectly because of too little
motion in the ankle joint. This occurs especially in case of small feet, heels that are moved forward, when walking
down stairs and ramps, and standing on surfaces that are sloping downwards. The maximum heel height in the
section "Technical data" must therefore be taken into account (see Page32).
9.1.1 Setting heel height using motion pattern
1) Put on shoes with the new heel height.
2) Stretch out foot with the prosthetic foot sideways.
3) Swing the foot to the side three times.
→A beep signal will sound to confirm that the motion pattern has been recognised.
4) Put feet at the same level and make sure the heel and toes are resting on the ground surface.
5) Distribute weight on feet evenly.
→A confirmation signal will sound to indicate that the new heel height was successfully stored.
INFORMATION: If there is no feedback (e.g. beep signal), this indicates that the new heel height could
not be stored. Repeat the heel height measurement.
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Use
1B1-2=* Meridium