Otto Bock E-MAG Active 17B203 User manual

17B203=* E-MAG Active
Instructions for use (qualified personnel) ................................................................. 3

2 17B203=* E-MAG Active

1 Introduction English
1.1 Foreword
INFORMATION
Last update: 2018-03-27
►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 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.
These instructions for use provide important information on the processing of the 17B203 E-MAG Active system
knee joints.
Please also read the instructions for use (user). Upon delivery of the orthosis, instruct the user regarding the func
tions of the E-MAG system. A quick start guide is also included, which provides 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.
1.2 Intended use
The product is intended exclusively for orthotic fittings of the lower limbs, for dynamic complete leg and knee
orthoses with a free swing phase and locked stance phase. The product can be installed using different types of
orthotic techniques. Ottobock recommends the lamination resin or prepreg technique.
1.3 Area of application
Max. body weight [kg]
Without medial support <85
With 17B206 medial support <100
1.4 Indication
INFORMATION
For further information on indications and patient prerequisites, we recommend consulting the brochure
646A214.
This product is suitable for the following indications:
Paresis and paralysis of knee stabilising muscles and muscle groups due to various fundamental diseases that
affect the spinal cord, the central nervous system, the peripheral nervous system or the musculature.
Physical prerequisites such as muscle status, mobility grade and axis deviations that guarantee proper control of
the orthosis are crucial. Additional indications and the selection of a suitable system for your patient mainly depend
on existing muscle strength, joint mobility and axis deviations, which, viewed collectively, determine patient suitabil
ity for one joint system or another.
1.5 Contraindications
Contraindications:
• Contractions in the knee joint that prevent relieving the knee joint lock
• Uncontrollable spasms
• Tuberosity supports
Additional contraindications when used without a medial support:
• Non-physiological deviations in the frontal plane (see fig.1)
• Non-physiological deviations in the sagittal plane (see fig.1)
• Instabilities of the capsular/ligamentous apparatus
Additional contraindications when used with a medial support:
• Flexion contractures in excess of 15°
317B203=* E-MAG Active
Introduction

mm (± 16 mm)
15 mm (± 17 mm)
16 mm (± 11 mm)
16 mm (± 9 mm)
60 mm (± 17 mm)
1In the sagittal plane, the vertical component of the ground
reaction force runs 60mm (±17mm) anterior to the ankle
pivot point, 15mm (±17mm) anterior to the knee joint pivot
point according to Nietert and 2mm (±16mm) posterior to
the Trochanter Major. In the frontal plane, the vertical com
ponent of the ground reaction force runs 16mm (±9mm)
laterally from the centre of the ankle and 16mm (±11mm)
laterally from the centre of the knee.
NOTICE
To ensure optimal functionality of the orthosis, the patient must generate a knee extension moment before heel lift-
off and also at heel strike.
Restriction of use:
INFORMATION
Not for use as a permanently locked orthosis with unilateral application.
1.6 Function and design
1.6.1 Function
The E-MAG Active is a knee joint system with stance phase control, which offers the user a free swing phase and
locks the knee joint for a secure stance phase prior to heel strike.
The E-MAG active is equipped with an electronic lock; the lock is released during toe-off, allowing the user to
swing the paralysed leg in a physiological manner. Prior to heel strike, the knee joint locks in the extended position
and the user can step down safely.
The E-MAG Active has an additional locking function (PreLock) that is activated at 15° of flexion. This secures the
patient even before the swing phase as such ends. Subsequently the knee joint is fully locked when it reaches the
extension stop.
1.6.2 Components
A Knee joint, upper section (stainless steel), mag
netic control with lock, cover (plastic)
B Knee joint, lower section (stainless steel)
ABC
2
C 30Y297=* dummy for knee joint
4
Introduction
17B203=* E-MAG Active

1.6.3 Electronic components
A Electronics / receptacle set (317B3/317Z13)
B Battery / receptacle set (317B20/317Z21)
C Battery charger (317L20)
D Dummy for battery receptacle (30Y103)
E Dummy for electronics receptacle (30Y100)
F Dummy for electronics (30Y123)
G Dummy for battery (30Y124)
H Battery cable and locking unit (317E20)
3
I Electronics cable (317E2)
1.6.4 Accessories
4 5
17LS3=16(-T) lamination joint bar for anchoring in lam
ination resin or prepreg technique – steel or titanium
(length 130mm, width 16mm, thickness 6mm bottom
and 3 mm top)
17B206 medial support – identical for left and right –
steel lamination joint bars for medial support =
17LS3=16(-T)
6
Medial support joint with dummy in 5° or 7.5° (not illus
trated)
INFORMATION
The subsequent conversion of the flexion components to 7.5° may only be completed by an authorised Ottobock
Service Centre.
1.6.5 Construction
The knee joint has a 6 mm posterior placement. This facilitates easy extension of the knee joint, which assures
problem-free unlocking.
517B203=* E-MAG Active
Introduction

The joint bushing (radial bearing) and bearing washer (axial bearing) are made of maintenance-free plastic. The
wedge lock is connected to an electronically controlled spring, which locks it to the lower joint section. The elec
tronic control unit consists of a gyroscope and 2D acceleration sensors to record the gait phase. It measures the
position while walking and releases the lock prior to toe-off while locking it again in the extended position prior to
heel strike.
The E-MAG Active has an additional locking function (PreLock) that is activated at 15° of flexion. This secures the
patient even before the swing phase as such ends. Subsequently the knee joint is fully locked when it reaches the
extension stop.
The open joint bar cases serve for attachment of the lamination bars. The electronic components are designed so
that they can be replaced by a technician. The batteries can be removed from the lamination frame and charged in
the charger. The charger has two ports so that two batteries can be charged simultaneously.
1.6.6 Support
Your national Ottobock team will be happy to answer any technical questions. Contact addresses and telephone
numbers are listed on the last page of this manual.
2 Safety
2.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
2.2 General safety instructions
INFORMATION
Certification (certificate of competence) for the E-MAG Active is mandatory. Without an orthopaedic technician
certified by name, the E-MAG Active is not CE compliant and therefore CE certification expires from an industrial
perspective.
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 author
ised, 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 compon
ents 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.
6
Safety
17B203=* E-MAG Active

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(-T) lamination bars with a torque value of
7.1Nm using Loctite® 241 (646K13).
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.
CAUTION
Risk of injury during trial fitting
We recommend fabricating a trial orthosis in order to verify the functionality and fit of the orthosis before the final
orthosis is constructed. 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 trial fitting between par
allel 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
Risk of injury due to unlocking of the knee joint
After activating the release mechanism / unlocking feature (switch to " "), the knee joint is not secured by the
E-MAG Active system. In order to use the system for walking (switch to " "), it must first be secured by reactivat
ing the release mechanism.
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.
717B203=* E-MAG Active
Safety

CAUTION
Unallowable use of lubricants
Risk of injury and loss of functionality as well as damage to the product
►The product is designed to be free of lubricants. Avoid contact with lubricants (e.g. grease, oil).
►After contact with lubricants, promptly clean the product or parts of the product with a degreasing cleaning
agent (e.g. acetone or isopropyl alcohol).
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 loading the orthosis, verify that the switch is in the desired position.
►Avoid accidentally opening or engaging the lock.
►Instruct the patient in the correct usage of the system joints.
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.
►In case of defective electronic components, always replace the entire component with a spare part.
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".
NOTICE
Thermal overloading of the product
Damage due to improper thermal treatment
►Do not carry out any heat treatment at a temperature above 300°C (570°F).
INFORMATION
When using the system in a knee orthosis, it is essential to ensure permanent firm fit of the orthosis.
8
Safety
17B203=* E-MAG Active

INFORMATION
Maintenance and repairs to the joint bearing are permitted. Repairs to the locking mechanism may only be per
formed by an Ottobock Service Centre.
3 Installation instructions
This section describes the steps for installing the E-MAG knee joint system in an orthosis. It also includes instruc
tions for fabricating a casing which, attached to the transfemoral socket, protects the electronics, cables and bat
tery housing from outside influences. The 17B203=* knee joint system was supplied to you as a complete package.
All required functional components are included, except for the medial support and lamination joint bars. The sys
tem is operational after installation and upon fully charging the battery.
NOTICE
Risk of damage to electronic components
Use the dummies included in the scope of delivery for all process steps until completion of the orthosis. Only
replace the dummies with the electronic components directly before trial fitting or upon completion of fabrication.
Only use the M5x10 screws included in the scope of delivery. The magnetic control on the upper section of the
orthosis is equipped with threaded blind holes to attach the lamination anchors. Using screws that are too long
may damage the control unit.
INFORMATION
We recommend the initial fabrication of a trial orthosis. This can be used for casting once the fit and functionality
are satisfactory. The risk of alignment problems is minimised by this approach. Alignment problems can result in
failure of the E-MAG knee joint system to extend fully, so that it cannot be opened and / or closed.
3.1 Installation of the E-MAG knee joint system
INFORMATION
The joint can be installed using different types of orthotic techniques. We recommend the lamination resin or
prepreg technique.
First model the plaster positive. Position the dummy (A) for the knee joint (B) (see fig.7) directly onto the Nietert’s
compromise pivot point with the help of the 743R6 joint alignment fixture (see fig.8). Align the medial support
dummy parallel to the E-MAG knee joint dummy.
7 8
The dummy is constructed such that the E-MAG knee joint has a 6 mm posterior placement. Now select the posi
tion of the electronic components. The battery and electronics are to be placed only on the thigh. This results in
favourable weight distribution. At the same time, the cable between the knee joint and electronics is not subjected
to unnecessary strain.
Select soft tissue regions that adapt easily to the form of the dummies. The dummies must lie flat on the selected
regions when forming the plaster positive. Otherwise, they may become curved through heat build-up during lamin
ation. This may prevent the original components from subsequently fitting into the recess (see fig.9). The manufac
turer recommends positioning the electronics and battery unit laterally on the orthosis. This prevents collision with
the contralateral side, especially for bilateral fittings.
917B203=* E-MAG Active
Installation instructions

9
When arranging the components, take the length of the cables into consideration:
• Battery – electronics: 50cm, variable length
• Electronics – knee joint: 30cm, fixed length
NOTICE
Risk of cable damage
Severing the cable destroys the cable between the knee joint and electronics. The cable between the knee joint
and electronics may not be shortened or extended. If it is too long, wrap it and fasten it to the orthosis.
Now draw the final position of the dummies onto the region of the thigh as follows:
• Dummy C for battery D with receptacle E (see fig.10)
• Dummy F for electronics G with receptacle H (see fig.11).
10 11
CAUTION
Risk of injury due to joint bar breakage
A broken joint bar can lead to injury of the patient. Carefully sand down and smoothen fissures and ridges of the
lamination joint bars before laminating the orthosis.
NOTICE
Risk of damage due to improper installation
When setting, ensure that the bending radius is not less than 15mm to avoid the risk of breaking. Grind away sur
face imperfections such as grooves and burrs caused during shaping. The joint bars must not be subjected to
heat treatment.
INFORMATION
The only function of the casing is to protect and fixate the battery, electronics and cable connections. The casing
only has to be large enough to enclose these components. The casing surface should be larger if patients have
requested padding on their transfemoral socket. In that case, the pad is glued directly onto the casing. Other
wise, the padding would have to be stripped and glued again every time a technician needs to access compon
ents that lie beneath.
10
Installation instructions
17B203=* E-MAG Active