Otto Bock E-MAG Active 17B203 User manual

Instructions for use (qualified personnel) ................................................................. 4
17B203=* E-MAG Active

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Weisen Sie den Benutzer in den sicheren Gebrauch des Produkts ein.Weitere Sprachen dieser Gebrauchsanweisung sind online verfügbar oder können kostenlos alsgedrucktes Exemplar bestellt werden (siehe Seite 2).DE |
Instruct the user how to use the product safely.These instructions for use are available in additional languages online or can be ordered as a printed copy free of charge (see page 2).EN |
Apprendre à l’utilisateur comment utiliser le produit en toute sécurité.D’autres langues de cette notice d’utilisation sont disponibles en ligne ou peuvent être commandées gratuitement en format papier (voir page 2).FR |
IT |
Explique al usuario cómo utilizar el producto de forma segura.Encontrará estas instrucciones de uso en otros idiomas en línea. También puede solicitarlo gratuitamente como ejemplar impreso (véase la página 2).ES |
Instrua o usuário sobre a utilização segura do produto.Outros idiomas destas instruções de uso estão disponíveis online ou podem ser solicitados gratuitamente como um exemplar impresso (veja a página 2).PT |
Leer de gebruiker hoe hij/zij veilig met het product moet omgaan.Andere talen van deze gebruiksaanwijzing zijn online beschikbaar of kunnen gratis in gedruktevorm worden besteld (zie pagina 2).NL |
Instruera användaren i hur produkten används på ett säkert sätt.Den här bruksanvisningen finns tillgänglig på andra språk online och kan beställas kostnadsfritti tryckt form (se sidan 2).SV |
2 17B203=* E-MAG Active

DA |
Instruer brukeren i sikker bruk av produktet.Flere språk for denne bruksanvisningen er tilgjengelige på nett, eller de kan bestilles som utskrevet eksemplar (se side 2).NO |
Perehdytä käyttäjä tuotteen turvalliseen käyttöön.Tämän käyttöohjeen muut kielet ovat saatavilla online tai niitä voi tilata maksutta painettuna versiona (katso sivu 2).FI |
CS |
Používateľa zaučte do bezpečného zaobchádzania s výrobkom.Ďalšie jazykové mutácie tohto návodu na použitie sú dostupné online alebo si možno bezplatne objednať ich tlačenú verziu (pozri strana 2).SK |
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就产品的安全使用给予用户指导。使用说明书的其他语言版本可在线获取，也可免费订购印刷版（参见第 2 页）。ZH |
Basic UDI-DI: 40327670000000017B203XL
317B203=* E-MAG Active

1 Foreword English
INFORMATION
Date of last update: 2023-09-29
►Please read this document carefully before using the product and observe the safety notices.
►Instruct the user in the safe use of the product.
►Please contact the manufacturer if you have questions about the product or in case of problems.
►Report each serious incident in connection with the product, in particular a worsening of the state of health, to
the manufacturer and to the relevant authority in your country.
►Please keep this document for your records.
These instructions for use provide important information on the processing of the 17B203 E–MAG Active orthotic
knee joint.
A quick start guide is available for the user, providing an overview of the E-MAG Active functions.
Provide the user with the instructions for use and the quick start guide upon delivery of the orthosis, and point out
the semi-annual maintenance intervals.
2 Product description
2.1 Available sizes
INFORMATION
The subsequent conversion of the E-MAG 5° flexion lower part to 7.5° may only be completed by an authorised
Ottobock Service Centre.
Article number Material Pre-flexion 17B206 medial support Max. body weight
17B203=L/R,
17B203=L/R-7.5
Steel 5° and 7.5° Without medial support Up to 85kg
17B203=L/R,
17B203=L/R-7.5
Steel 5° and 7.5° With medial support Up to 100kg
2.2 Function/design
Function
The E-MAG Active is an orthotic joint with stance phase control which offers the user a free swing phase and locks
the orthotic joint for the stance phase prior to heel strike.
The E-MAG Active features an electronic lock that is released during toe-off, allowing the user to swing the para
lysed leg in a physiological manner. Prior to heel strike, the orthotic joint locks in the extended position so the user
can step down safely.
The E-MAG Active has an additional locking function (PreLock) that is activated at 15° flexion. This secures the
patient even before the actual swing phase ends. The orthotic joint is then fully locked when it reaches the exten
sion stop.
Design
The bushing (radial bearing) and axial washer (axial bearing) are made of maintenance-free plastic. The lock
wedge is electronically controlled via an electromagnet. The electronic control unit consists of a gyroscope and 2D
acceleration sensors to record the gait phase. It measures the position while the user is walking and unlocks the
orthotic joint prior to toe-off and then locks it again in the extended position prior to heel strike.
The open insertion zones serve to attach the lamination bars. The electronic components are designed to be
replaced by a technician. The battery can be removed from the battery receptacle on the orthosis and charged in
the charger. The charger has two ports so two batteries can be charged simultaneously.
4 17B203=* E-MAG Active
Foreword

2.3 Components/design
192021181716151213101411986752431
1
Scope of delivery (see fig.1)
Item Piece(s) Designation Article number
1 1 Orthotic joint 17B203*
2 1 Lamination dummy 317X203*
3 1 Battery cable 317E20
4 1 Ratchet unit 317R20
5 1 Electronics cable 31E2
6 2 Battery 317B20
1 Battery receptacle set, consisting of:
Item7 Battery receptacle
Item8 Dummy for battery receptacle
Item9 Dummy for battery
317Z21
10 1 Electronics 317B3
12 1 Cable dummy 30Y140
1 Electronic frame set, consisting of:
Item11 Electronics receptacle
Item13 Dummy for receptacle
Item14 Dummy for electronics
317Z13
15 1 Perlon cable 21A45*
16 4 Oval head screws 501S72
17 4 Screws 501S137=M5x10
18 1 Slotted oval head screw 501T128=M6x20
1 Battery charger, consisting of:
Item19 Power supply unit
Item20 US plug
Item21 Charging cradle
317L20
Not illus
trated
1 E-MAG Active instructions for use, qualified
personnel
647G1165
Not illus
trated
1 E-MAG Active instructions for use, users 647H648
Not illus
trated
1 Battery charger instructions for use 647G310
Not illus
trated
1 Instructions for use for rechargeable battery 647G309
Not illus
trated
1 Quick start guide – E-MAG Active 646H17
Not illus
trated
1 Orthotic Passport 646H9
517B203=* E-MAG Active
Product description

Scope of delivery (see fig.1)
Item Piece(s) Designation Article number
Not illus
trated
1 Support addresses 647G339
2
Scope of delivery (see fig.2)
Item Piece(s) Designation Article number
1 1 Joint screw 30Y112
2 1 Axial washer 17BS203
3 1 Lower joint section 30U134=*
4 4 Countersunk screws 501S137=M5x10
5 1 Stop bumpers 617G28=3-9
6 1 Cylinder pin 506A8=4x8
7 1 Collar bushing 30Y295=*
8 1 Upper joint section 30X96=*
9 1 Unlocking mechanism 30Y353=*
10 1 Cover 30Y440=*
11 1 Phillips countersunk screws 501S21=M2x5
12 1 Lamination dummy 30Y297=*
13 1 Cap screw 501T28=M6x20
Not included in scope of delivery
Item Piece(s) Designation Article number
14 1 Lamination bar 17LS3=16, 17LS3=16–T
15 1 Lamination bar 17LS3=16, 17LS3=16–T
Not illus
trated
1 Side bar 17LV3=16, 17LV3=L/R-16
6
Product description
17B203=* E-MAG Active

3 Intended use
3.1 Indications for use
The product is intended exclusively for orthotic treatment of the lower limbs, for dynamic knee-ankle-foot orthoses
and knee orthoses with a free swing phase and locked stance phase. Ottobock recommends using the lamination
bars for the lamination and prepreg technique and side bars for the thermoplastic technique.
3.2 Indications
INFORMATION
To ensure optimal functionality of the orthosis, the patient must generate a knee extension moment before heel lift-
off and also at heel impact.
Partial or total paralysis of the leg muscles.
Indications must be determined by the physician.
Ottobock recommends the 646A214 “Therapeutic Application and Gait Training” brochure.
3.3 Contraindications
Contraindications:
• Knee flexion contractures in excess of 15° that prevent the knee joint lock from being relieved
• Hip flexion contractures
• Uncontrollable spasticity
• Ischial support
• Non-physiological deviation in the frontal plane
3.4 Lifetime
The product is designed for a lifetime of 3years when used as intended and assembled professionally.
3.5 Qualification
Patients may be fitted with the product only by trained qualified personnel. The qualified personnel must be familiar
with the handling of the various techniques, materials, machines and tools.
3.6 Combination possibilities
The 17B203* E-MAG Active orthotic joint can be combined with the medial support 17B206*.
132
31. Slotted oval head screw for lamination dummy
501T28=M6x16
2. 317X206, 317X206=7.5 Lamination dummy
for medial support in 5 or 7.5° (not illustrated)
3. 17B206, 17B206=7.5 Medial support
4 Safety
4.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
717B203=* E-MAG Active
Intended use

4.2 Safety instructions
CAUTION
Risk of falling due to improper use
Provide your patient with precise instructions on the operation and use of the E-MAG Active. Be sure to inform
your patient that, in case of improper use, the joint cannot release prior to toe-off or the swing phase, or cannot
lock prior to heel strike. Also inform your patient of the PreLock function.
CAUTION
Mechanical damage to the product
Injuries due to changes in or loss of functionality
►Use caution when working with the product.
►Check the product for proper function and readiness for use.
►In case of changes in or loss of functionality, discontinue use of the product and have it checked by autho
rised, qualified personnel.
CAUTION
Risk of injury due to the use of unapproved components or spare parts
Components and spare parts that have not been authorised by the manufacturer may break. Only use compo
nents and spare parts approved by the manufacturer for installation and service.
CAUTION
Explosion hazard
Do not throw the battery into fire. Never expose it to heat. Avoid direct sunlight. Please pass this information on to
your patient.
CAUTION
Excessive strain on load-bearing components
Injuries due to changes in or loss of functionality
►Only use the product for the defined area of application.
►If the product has been exposed to extreme strain (e.g. due to falling), take any necessary measures (e.g.
repair, replacement, inspection by the manufacturer's customer service etc.).
CAUTION
Risk of injury due to system joint bars coming loose
Secure the countersunk head screws for attaching the 17LS3=16, 17LS3=16-T lamination bars with a tightening
torque of 7Nm using 646K13 Loctite 241.
CAUTION
Risk of pinching
Ensure freedom of movement during flexion. Do not allow sockets to overlap. The knee joint has a maximum flex
ion angle of 140°.
CAUTION
Risk of falling due to incorrect calibration
During auto-calibration, proceed according to the prescribed steps in order to avoid accidentally triggering the
joint.
CAUTION
Risk of falling due to improper operation of the service buttons
You must inform the patient that the service buttons must not be activated or manipulated.
8
Safety
17B203=* E-MAG Active

CAUTION
Risk of injury during fitting
We recommend fabricating a trial orthosis in order to verify the functionality and fit before the final orthosis is con
structed. Patient suitability can also be verified by following this process. Ensure that the patient is standing
securely during this process in order to eliminate the risk of falling. Carry out the fittings between parallel bars.
CAUTION
Risk of injury due to incorrect patient selection
In the selection of patients, ensure that the patient can fully extend the knee during heel lift-off and heel strike.
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 personnel.
►Observe the alignment, assembly and adjustment instructions.
CAUTION
Exposure of the product to unsuitable environmental conditions
Patient injury, damage, brittleness or destruction due to improper handling
►Do not expose the product to condensing ambient humidity or liquids.
►Do not expose the product to abrasive substances (e.g. sand, dust).
►Do not expose the product to temperatures below -10°C (14°F) or above +60°C (140°F) (e.g. sauna,
excessive sunlight, drying on a radiator).
CAUTION
Improper handling
Risk of falling due to accidentally opening or engaging the lock
►Before placing weight on the orthosis, verify that the lock is in the desired position.
►Avoid accidentally opening or engaging the lock.
►Instruct the patient in the correct handling of the orthotic joints.
NOTICE
Thermal overloading of the orthosis joint
Damage to the bearing washers due to improper thermal treatment, loss of orthosis joint movement
►Do not carry out any heat treatment.
►Check the function of the orthosis joint.
►Replace damaged bearing washers.
CAUTION
Knee not fully extended at heel strike
Risk of injury due to unlocked orthosis joint
►Fully extend the knee prior to heel strike.
NOTICE
Risk of damage to electronic components due to installation errors or improper use
Incorrect handling of the electronics can cause malfunctions and/or damage to the electronics. Please observe
the following safety instructions:
►Please read the information regarding the operation of the electronics thoroughly and instruct the patient in
the use of the electronics (see the information on the functionality of electronic components).
►Only install electronic components in the thigh area.
►All electronic connections should be protected against oxidisation with silicone grease.
►Only use the M5x10 screws included in the scope of delivery.
►If electronic components are defective, always replace the entire component with a spare part.
917B203=* E-MAG Active
Safety

NOTICE
Contact with salt water or water containing chlorine/soap as well as abrasive substances (e.g. sand)
Damage and premature product wear
►Following any contact with the substances identified above, promptly clean the product in accordance with
the section "Cleaning and care".
INFORMATION
When using the system in a knee orthosis, take care to ensure that the orthosis is permanently positioned on the
leg.
INFORMATION
Maintenance and repairs to the orthotic knee joint in the area of the bearing are permitted. Repairs to the locking
mechanism may only be performed by an Ottobock Service Centre.
5 Preparing the product for use
NOTICE
Damage to the control electronics
Use the dummies included in the scope of delivery for all process steps until the orthosis is completed. Only
replace the dummies with the electronic components directly before the fitting or upon completion of fabrication.
The upper joint section of the orthotic joint has threaded blind holes to attach the lamination bars. To avoid dam
aging the control electronics in the upper joint section of the orthotic joint, only use the supplied M5x10 screws.
INFORMATION
We recommend fabricating an interim orthosis prior to the definitive orthosis. This makes it possible to prevent
alignment errors and incorrect positioning of the E-MAG Active orthotic joint and to check that the orthotic joint is
opened and closed reliably.
INFORMATION
Parallel alignment of the orthotic joints
Use the 743R6 alignment fixture to position the orthotic joints on the plaster positive.
Using the lamination dummy
Positioning of the electronic components
The electronic components are positioned laterally on the thigh. This prevents a collision with the contralateral side
in bilateral fittings. The optimal position for the electronics is proximal and in the vertical course of the load line. If
the electronics and battery are located on one side of the thigh, the cable between the electronics and battery is
not subjected to unnecessary strain. Optional: The battery can also be positioned on the medial side of the thigh.
123
4Model the patient-specific plaster positive.
Position the lamination dummy 30Y297* (item2) of the
orthotic joint (item3) on the compromise pivot point
according to Nietert using the slotted oval head screw
(item1) and the 743R6 joint alignment set.
10
Preparing the product for use
17B203=* E-MAG Active