Otto Bock Myo Plus, Instructions For Use Manual

Page 1: ...Instructions for use qualified personnel 5 Myo Plus...

Page 2: ...the instructions for use Angewandte Symbole Symbole Used Symboles utilis s Simboli utilizzati S mbolos utilizados S mbolos utilizados Gebruikte symbolen Symboler som anv nds Anvendte symboler Benytted...

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Page 4: ...1 2 3 4 5 7 8 6 1 2 3 4 5 7 8 6 1 2 3 13E190 4...

Page 5: ...ly put the product into use in accordance with the information contained in the accompanying documents supplied According to the manufacturer Otto Bock Healthcare Products GmbH the patient is the oper...

Page 6: ...Hand DMC plus 8E38 6 8E39 6 Sensor Hand Speed 8E38 8 8E39 8 MyoHand VariPlus Speed 8E38 9 8E39 9 8E41 9 Transcarpal Hand DMC plus 8E44 6 System Electric Greifer DMC VariPlus 8E33 9 8E34 9 DMC VariPlu...

Page 7: ...echnical qualifications required for the alignment of a prosthesis with all required settings and adjustments The user must be instructed about the use of the product by authorised qualified personnel...

Page 8: ...ents in the section Scope of delivery and accessories WARNING Changes or modifications to the product made independently Injury due to faulty operation or malfunction of the product Have any changes o...

Page 9: ...CAUTION Skin irritation due to inadequate cleaning of the product Skin irritation due to contact with soiled electrode domes Clean the product only as described in the section Cleaning and care see pa...

Page 10: ...the electrode domes Applying thread locking compound forms an insulating layer that prevents transmission of the EMG signals NOTICE Failure to observe the system requirements for the installation of...

Page 11: ...n Required tools Drill twist drill 5 mm The remote electrodes have to be positioned as follows 1 Mark the position of remote electrode 1 below the ulna and 6 7 cm distal of the olecranon 2 Extend the...

Page 12: ...s and wiring can be protected against moisture and dirt with film or adhesive tape 7 4 Installing the Myo Plus TR The Myo Plus TR can be secured on the inner socket with adhesive tape or a hook and lo...

Page 13: ...ing a connection to the coaxial plug The following steps are required to connect the Myo Plus TR to a coaxial plug 1 2 3 4 5 7 8 6 4 Connect the cables of the Myo Plus TR to the coaxial plug see fig 4...

Page 14: ...on the supplied Bluetooth PIN card can be read with the mobile device requirement QR code reader and camera 8 1 System Requirements See the information in the Apple App Store or Google Play Store rega...

Page 15: ...s app 6 1 Access online help 2 Display and name of the currently selected motion sequence 3 Connection to component has been established 4 Display of the selected screen 5 Display of the currently sel...

Page 16: ...is 9 Use All electrode signals are displayed in the Myo Plus app via the Myo Plus TR The product is set up and configured via the Myo Plus app All information on use is found in the menu texts of the...

Page 17: ...for medical devices This product meets the requirements of the 2014 53 EU directive The product meets the requirements of the RoHS Directive 2011 65 EU on the restriction of the use of certain hazardo...

Page 18: ...d 2 this device must accept any interference including interference that may cause undesired operation of this device L utilisation de ce dispositif est autoris e seulement aux conditions suivantes 1...

Page 19: ...voltage 6 V 11 1 V DC Current draw Max 25 mA Power supply 757B35 3 5 MyoEnergy Integral or 757B20 757B21 Energy Pack Lifetime 5 years Operating time MyoBock hand approx 14 hours bebionic hand approx 8...

Page 20: ...indicat or Event Charge level above 50 illuminated in green and Charge level below 50 flashing alternating green and orange Charge level below 5 illuminated in orange 13 1 2 Beep signals The followin...

Page 21: ...3 Symbols Used Type BF applied part Declaration of conformity according to the applicable European directives In some jurisdictions it is not permissible to dispose of these products with unsor ted ho...

Page 22: ...devices is unlikely Harmonics according to IEC 61000 3 2 Not applicable power below 75 W Voltage fluctu ations flicker accord ing to IEC 61000 3 3 Product meets the requirements of the standard Electr...

Page 23: ...0 to 390 TETRA 400 Pulse modu lation 18 Hz 1 8 0 3 27 450 430 to 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kHz sine 1 8 0 3 28 710 745 780 704 to 787 LTE band 13 17 Pulse modu lation 217 Hz 0 2 0 3 9...

Page 24: ...203 Otto Bock Healthcare Products GmbH Brehmstra e 16 1110 Wien Austria T 43 1 523 37 86 F 43 1 523 22 64 info austria ottobock com www ottobock com The product is covered by the following patents Pat...