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

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

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

  • Page 1 17B203=* E-MAG Active Instructions for use (qualified personnel) ..............
  • Page 2 order-ifu@ottobock.com Documentu 647G1165 Versionu 08 SCAN ME httpsu//product-documents.ottobock.com/IFU/INT/17B203/647G1165/08/O/S/F DE | Weisen Sie den Benutzer in den sicheren Gebrauch des Produkts ein. Weitere Sprachen dieser Gebrauchsanweisung sind online verfügbar oder können kostenlos als gedrucktes Exemplar bestellt werden (siehe Seite 2). EN | Instruct the user how to use the product safely.
  • Page 3 DA | Instruér brugeren i, hvordan ban produktet anvendes på sikker vis. Denne brugsanvisning er tilgængelig på yderligere sprog online eller kan bestilles gratis sob et trykt eksebplar (se side 2). NO | Instruer brukeren i sikker bruk av produktet. Flere språk for denne bruksanvisningen er tilgjengelige på...

  • Page 4: Product Description

    Foreword English 1 Foreword 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. ►...
  • Page 5 Product description 2.3 Components/design Scope of delivery (see fig. 1) Item Piece(s) Designation Article number Orthotic joint 17B203* Lamination dummy 317X203* Battery cable 317E20 Ratchet unit 317R20 Electronics cable 31E2 Battery 317B20 Battery receptacle set, consisting of: 317Z21 Item 7 Battery receptacle Item 8 Dummy for battery receptacle Item 9 Dummy for battery Electronics...
  • Page 6 Product description Scope of delivery (see fig. 1) Item Piece(s) Designation Article number Not illus­ Support addresses 647G339 trated Scope of delivery (see fig. 2) Item Piece(s) Designation Article number Joint screw 30Y112 Axial washer 17BS203 Lower joint section 30U134=* Countersunk screws 501S137=M5x10 Stop bumpers 617G28=3-9...

  • Page 7: Intended Use

    Intended use 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.
  • Page 8 Safety 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.
  • Page 9 Safety 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.

  • Page 10: Preparing The Product For Use

    Preparing the product for use 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".
  • Page 11 Preparing the product for use Arrange the 30Y297=* and lamination 317X206=* dum­ mies for the orthotic joints parallel to each other. Determine the final positions of the lamination dummies on the region of the thigh. Components: 1. Battery 2. Receptacle casing 3.
  • Page 12 Preparing the product for use 2) Secure and align the lamination dummy on the model using the slotted oval head screw and the alignment insert. 3) Process the bars according to their instructions for use (647G1425). Mounting the bar 1) Clean the threads of the screw connections using a degreasing cleaner. 2) Insert the bars into the insertion zone.
  • Page 13 Preparing the product for use NOTICE Risk of damage due to improper installation Incorrect installation can cause malfunctions and/or damage to the orthotic joint. Please observe the following safety instructions: ► Follow the instructions for use provided for the charger and battery. ►...
  • Page 14 Preparing the product for use Measure the length of the supplied cable dummies: • Cable dummy (7 mm wide) between the lamination dummies for the knee joint and electronics. • Perlon wire for the cable connecting the electronics to the battery. Secure the lamination dummies for the electronic com­...
  • Page 15 Preparing the product for use Fully demould the orthosis from the model and remove all dummies and the plasticine. Sand down the edges of the orthosis and the casing. Insert the dummy (item 2) for the rechargeable battery into the corresponding receptacle (item 1). Position the receptacle in the casing from the outside.
  • Page 16 Preparing the product for use INFORMATION: This example shows the use of 4 mm PP homopolymer 616T20*. Expose the square channels for the alignment inserts. Bend the bars. Orthosis with curved bars. Fabricating the casing using thermoplastic technology CAUTION Risk of damage due to improper processing Injuries due to changes in or loss of functionality ►...
  • Page 17 Preparing the product for use Position the lamination dummies for the electronic com­ ponents 30 mm from the edge of the upper part of the orthosis. Measure the length of the supplied cable dummies: • Cable dummy (7 mm wide) between the lamination dummies for the knee joint and electronics.
  • Page 18 Preparing the product for use Demould the casing after it cools. Carefully sand down the lamination dummies of the bat­ tery and its receptacle as well as the electronics and their receptacle to the edges. Fully demould the orthosis from the model and remove all dummies and the plasticine.
  • Page 19 Preparing the product for use 3) Secure the screws with Loctite 241 and the corresponding tightening torque. 4) Prepare the paddings and hook-and-loop closures. 5.2 Installing the electrical components NOTICE Risk of cable damage Shortening, extending and frequent bending can destroy the cables between the joint and electronics, and between the battery and electronics.
  • Page 20 Preparing the product for use Connect the cable clips to the electronics shell. INFORMATION: Ensure that the cable clips engage firmly. INFORMATION: Leave 5 cm additional cable length to allow for installation of the locking unit. Ensure the correct polarity is maintained after shortening: plus cable (red) to plus connection (+ symbol on locking unit), minus cable (grey) to minus (no sym­...
  • Page 21 Preparing the product for use Place the plug in the battery tray. Insert the locking unit into the battery tray. Install cable from electronics rechargeable battery and secure it in the cable channel of the casing with double-sided adhesive tape. INFORMATION: Apply 633F11 silicone grease to protect the contacts and cable connections against oxidation.
  • Page 22 Preparing the product for use Insert the electronics into the receptacle. Fasten the electronics using the supplied screws at a maximum torque of 1 Nm. Connect the electronics cable to the orthotic joint: Loosen the countersunk screws (item 3) and remove the cover (item 4). Apply silicone grease to the contacts of the plug con­...
  • Page 23 Preparing the product for use Screw the cover onto the orthotic joint. Secure the casing on the upper part of the orthosis. Once the rechargeable battery is inserted and fully charged, the orthotic joint is ready for operation. 5.3 Working instructions for electronic components 5.3.1 Control electronics The electronic control unit measures the position of the orthosis during the gait cycle and unlocks the orthotic joint prior to toe-off.
  • Page 24 Preparing the product for use 3) Sensor error. Continuous illumination (red) and continuous tone. Remove and then reinsert the battery. 5.3.1.2 Initial walking in test mode Perform initial walking attempts (Figuresee fig. 46) between parallel bars or at least with the help of crutches. In order to make the orthotic joint easy to unlock, a test mode can be activated which does not look for an optimised setting but instead opens the orthotic joint in a defined toe-off position (provided the patient’s knee joint is exten­...
  • Page 25 Preparing the product for use 5) The software now reports that the orthotic joint is in calibration mode. The patient can then walk in the locked state until the software uses a different audible tone to warn the patient that the orthotic joint is about to auto­ matically unlock at the end of the stance phase in order to facilitate an unobstructed swing-through.
  • Page 26 Preparing the product for use CAUTION Risk of falling due to unlocking/locking Both permanent and one-time unlocking as well as permanent locking of the orthotic joint can result in an elevated risk of falling. The patient should not use these functions whilst walking. 5.3.1.9 Alarm configuration Signal Visual feedback (LEDs)

  • Page 27: Maintenance

    Cleaning 6 Cleaning After contact with water containing salt, chlorine or soap, or if they get dirty, the orthotic joints must be promptly cleaned. 1) Clean the joint with a damp cloth when needed. 2) Dry it with a lint-free cloth and allow it to air dry fully. Do not expose to direct heat sources (e.g. sunlight, stove or radiator).
  • Page 28 Maintenance 3) Optional: Replace the axial washer (item 2). INFORMATION: Only use a washer of the same colour when replacing the axial washer contained in the 17BS203 maintenance set. 4) Optional: Replace the bearing bushing (item 7) (included in the 17BS203 maintenance set). 5) Optional: replace the Eladur bumper (item 5) (included in the 17BS203 maintenance kit).

  • Page 29: Faults And Troubleshooting

    Faults and troubleshooting 8 Faults and troubleshooting NOTICE Risk of short circuit Never open electronic components. If there is a defect, send all electronic components to Ottobock. Optional: Replace the 317E2 electronics cable and the 317E20 battery connection cable. INFORMATION The orthotic joint remains locked when the electronic components fail.

  • Page 30: Legal Information

    Disposal 11 Disposal Dispose of the product in accordance with national regulations. 12 Legal information All legal conditions are subject to the respective national laws of the country of use and may vary accordingly. 12.1 Liability The manufacturer will only assume liability if the product is used in accordance with the descriptions and instruc­ tions provided in this document.
  • Page 31 17B203=* E-MAG Active...
  • Page 32 Ottobock SE & Co. KGaA Max-Näder-Straße 15 · 37115 Duderstadt · Germany T +49 5527 848-0 · F +49 5527 848-3360 healthcare@ottobock.de · www.ottobock.com...