Otto Bock E-MAG Active 17B203 Instructions For Use Manual
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Otto Bock E-MAG Active 17B203 Instructions For Use Manual

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

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Summary of Contents for Otto Bock E-MAG Active 17B203

  • Page 1 17B203=* E-MAG Active Instructions for use (qualified personnel) ..............
  • Page 2 17B203=* E-MAG Active...
  • Page 3 Introduction English 1 Introduction 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. ►...
  • Page 4 Introduction In the sagittal plane, the vertical component of the ground reaction force runs 60 mm (±17 mm) anterior to the ankle 2 mm (± 16 mm) pivot point, 15 mm (±17 mm) anterior to the knee joint pivot point according to Nietert and 2 mm (±16 mm) posterior to 15 mm (±...

  • Page 5: Electronic Components

    Introduction 1.6.3 Electronic components Electronics / receptacle set (317B3/317Z13) Battery / receptacle set (317B20/317Z21) Battery charger (317L20) Dummy for battery receptacle (30Y103) Dummy for electronics receptacle (30Y100) Dummy for electronics (30Y123) Dummy for battery (30Y124) Battery cable and locking unit (317E20) Electronics cable (317E2) 1.6.4 Accessories 17LS3=16(-T) lamination joint bar for anchoring in lam­...

  • Page 6: Explanation Of Warning Symbols

    Safety 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.
  • Page 7 Safety 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.).
  • Page 8 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.

  • Page 9: Installation Instructions

    Installation instructions 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...
  • Page 10 Installation instructions 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.
  • Page 11 Installation instructions Remove all dummies except for the E-MAG knee joint dummy and set up the lamination joint bars (see fig. 12). The drilled holes in the system box of the knee joint are used to temporarily fasten the lamination joint bars with a screw during alignment of the orthosis until trial fitting.
  • Page 12 Installation instructions CAUTION Risk of damage due to improper installation Ensure that no notches are made in the joint bar material during milling since this creates predetermined breaking points. Measure the length of the accompanying cable dummies: • Dummy for the cable between the knee joint and electronics (7 mm wide, see fig. 17) •...
  • Page 13 Installation instructions Reinforce the casing as follows: • PVA bag • 2 layers of perlon stockinette, reinforced with carbon INFORMATION The carbon maintains the tension of the casing and secures the dummies and screw connections. • 2 additional layers of perlon stockinette •...

  • Page 14: Final Assembly

    Installation instructions Fasten the unit from the outside with PVC adhesive tape. Seal off the unit as much as possible by pulling the tape tight. NOTICE Damage to the receptacle Sealing resin inside the receptacle can damage the latter. Resin dissolves the material of the receptacle. Do not let resin leak into the receptacle.
  • Page 15 Installation instructions Then connect the electronics cable to the battery. Place three to four small strips of double-sided adhesive tape – depending on cable length – into the cable channel. Glue the cable into the casing (see fig. 29). You may shorten the battery cable in the battery plug section.
  • Page 16 Installation instructions marked red marked red INFORMATION The E-MAG knee joint is equipped with polarity protection: In case of incorrect polarity, a short-circuit is avoided by turning off the electronics. If the E-MAG knee joint system fails to indicate operational readiness for no appar­ ent reason (see Section 5.2) after the cables are connected, please check the polarity.
  • Page 17 Installation instructions Insert the electronics into the receptacle (see fig. 36) and fasten with the enclosed screws (see fig. 37) at a maxim­ um torque of 1 Nm. Please observe the precise positioning of the electronics and the receptacle. CAUTION Risk of injury due to screws coming loose The patient may fall and sustain injury if the bars loosen from the joint connections.

  • Page 18: Control Electronics

    Working instructions for electronic components Screw the casing onto the transfemoral socket. Finally, insert the battery and verify all functions. Provide the user with the instructions for use and quick start guide, and explain the functions of the E-MAG knee joint upon delivery. Be sure to point out the semi-annual maintenance interval.
  • Page 19 Working instructions for electronic components Button to lock the knee joint and for calibration (Service) button for test mode/ (Service) button for acoustic mode auto-calibration Button to unlock sitting position and for calibration 4.1.1 Power-on self test – initial battery installation After all cables are connected, the battery can be inserted.

  • Page 20: Auto Calibration

    Working instructions for electronic components Test settings Push and hold test mode Push and hold top Push and hold lower button (T) until light button (B) until light button (C) until light signal/tone is emitted signal/tone is emitted signal/tone is emitted 4.1.3 Auto-calibration INFORMATION Auto-calibration requires the battery to be removed and reinserted after the test mode.
  • Page 21 Working instructions for electronic components 3) The patient is asked to step ahead with the leg that is fitted with the orthosis (position similar to heel strike). While the patient briefly remains in this position, the technician confirms the position by pressing the top button B (see Page ).
  • Page 22 Working instructions for electronic components CAUTION Risk of falling due to unlocking / locking Both permanent and one-time unlocking as well as permanent locking of the system can result in an elevated risk of falling. The patient should not use these functions whilst walking. 4.1.10 Alarm configuration Signal Visual feedback (LEDs)

  • Page 23: Maintenance Instructions

    Maintenance instructions 5 Maintenance instructions 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). ►...
  • Page 24 Maintenance instructions INFORMATION The bearing washer (A) and the bearing bushing (B) can be replaced if required. Only use soap and water for cleaning. When replacing the bearing washer, please make sure to use always washers of the same colour. 35Nm To open the lock, loosen the two screws at the right and left of the cap.
  • Page 25 Maintenance instructions Outside the warranty period, the service set is subject to a rental fee. When sending the E-MAG Active for service, please be sure to include all of the following components: electronics, battery, battery charger, case with serial number. 5.2.1 System does not start properly If the system does not initialise properly, remove the battery, wait 30 seconds and reinsert it.

  • Page 26: Maintenance Schedule

    Maintenance instructions 5.3 Maintenance schedule Maintenance schedule for regular service E-MAG Active Patient: 1st used Serial number: Patient weight [kg]: ....Left □ Right □ Body height [cm]: ....Inspection (check list) Medial support serial num­ ber: Item Range Measures Knee joint Dirt/wear? Play in the joint when locked (ML)?

  • Page 27: Technical Data

    Technical data 6 Technical data Storage temperature range -20 °C to +70 °C (-4 °F to 176 °F) Operating temperature range -15 °C to +50 °C (-5 °F to 122 °F) Relative humidity for both ranges 0 % to 100 % Power supply for joint NiMh battery, 4.8 V nominal voltage Range of a battery pack Approx.
  • Page 28 Ottobock SE & Co. KGaA Max-Näder-Straße 15 · 37115 Duderstadt · Germany T +49 5527 848-0 · F +49 5527 72330 healthcare@ottobock.de · www.ottobock.com...

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