Otto Bock Myo Plus Instructions For Use Manual
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- Quick manual (13 pages)
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Summary of Contents for Otto Bock Myo Plus
- Page 1 Myo Plus Instructions for use (qualified personnel) ................
- Page 2 Caution: Federal law (USA) restricts this device to sale by or on the order of a practitioner licensed by law of the State in which he/she practices to use or order the use of the device. Quick Reference Guide This "Quick Reference Guide" does not replace the instructions for use Angewandte Symbole / Symbole Used / Symboles utilisés / Simboli utilizzati / Símbolos utilizados / Símbolos utilizados / Gebruikte symbolen / Symboler som används / Anvendte symboler / Benyttede sym...
- Page 4 13E190...
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Page 5: Product Description
The product measures the patient's control signals and assigns them to the prosthesis move ments. By calibration via the Myo Plus app, the control unit learns to assign the sampled muscle signals to the various movement types. This calibration can be carried out directly by the user and repeated at regular intervals. -
Page 6: Intended Use
10S1=* lamination ring Rechargeable battery • 757B35=5 MyoEnergy Integral • 757B35=3 MyoEnergy Integral • 757B20 EnergyPack • 757B21 EnergyPack 3 Intended use 3.1 Indications for use Myo Plus is to be used exclusively for exoprosthetic fittings of the upper limbs. - Page 7 3.2 Conditions of use The product was developed for everyday use and must not be used for unusual activities such as extreme sports (free climbing, paragliding, etc.). Furthermore, the product must not be used for the operation of motor vehicles, heavy equipment (e.g. construction machines), industrial machines, firearms or motor-driven equipment.
- Page 8 4.3 General safety instructions WARNING Non-observance of safety notices Personal injury/damage to the product due to using the product in certain situations. Observe the safety notices and the stated precautions in this accompanying document. ► WARNING Operating the product near medical devices critical for safety Interference with life-sustaining medical devices (e.g., pacemaker, defibrillator, heart-lung machine, etc.) due to electromagnetic interference of the product.
- Page 9 CAUTION Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention systems, metal detectors) Injury due to unexpected behaviour of the product caused by interference with internal data communication. Avoid remaining in the vicinity of visible or concealed theft prevention systems at the ►...
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Page 10: Scope Of Delivery And Accessories
Failure to observe the system requirements for the installation of the Myo Plus app Malfunction of the device. Install the Myo Plus app only on the operating systems listed in the section "System require ► ments" (see page 14). The tested devices are listed in this section as well. -
Page 11: Charging The Battery
• 13Z163 electrode dome, high ▀ (6 pc. per package) • Myo Plus app 6 Charging the battery We recommend charging on a daily basis. If the device is not used for an extended period, the battery charge level should be checked regularly and the battery recharged. - Page 12 Fabricate the outer socket using the familiar technique. The "No Carbon Zone" label can be applied to the Myo Plus TR dummy as an aid for the lamination of carbon sockets. 7.3 Inserting electrodes CAUTION Improper securing of the electrode domes Injury due to product malfunction.
- Page 13 7.5.1 Establishing the connection to the electric wrist rotator The following steps are required to connect the Myo Plus TR to the electric wrist rotator: ► Connect the cables of the Myo Plus TR to the rotation adapter (see fig. 3).
- Page 14 The Myo Plus app can be downloaded free of charge from the respective online store. To down load the Myo Plus app, the QR code on the supplied Bluetooth PIN card can be read with the mobile device (requirement: QR code reader and camera).
- Page 15 3) Accept the end user licence agreement (EULA). If the end user license agreement (EULA) is not accepted, the Myo Plus app cannot be used. 4) The "Bluetooth connection" menu item is opened. 5) Tap to establish a connection. 6) Select the desired component from the list.
- Page 16 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 app and in the online help.
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Page 17: Cleaning And Care
11.3 CE conformity Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with applicable European requirements for medical devices. This product meets the requirements of the 2014/53/EU directive. -
Page 18: Technical Data
Caution: Exposure to Radio Frequency Radiation. This device must not be co-located or operating in conjunction with any other antenna or transmit ter. Responsible party: Otto Bock Health Care, LP 3820 West Great Lakes Drive Salt Lake City, Utah 84120-7205 USA Phone + 1-801-956-2400 Fax + 1-801-956-2401 This device complies with RSS 210 of Industry Canada. - Page 19 Water vapour pressure up to 50 hPa Operation +5 °C/41 °F to +40 °C/104 °F 15% to 90% relative humidity, non-condens ing; air pressure 533 hPa to 1060 hPa Myo Plus TR Reference number 13E520 Dimensions 67 x 27 x 9.2 mm/2.64 x 1.1 x 0.36 inch Weight 15 g/0.53 oz...
- Page 20 13 Appendices 13.1 Operating States 13.1.1 Status signals Charge level of the 757B35=* MyoEnergy Integral battery Charging Event receptacle Battery fully charged (illuminated in green) Battery 50% charged (illuminated in yellow) Battery drained (illuminated in orange) The battery charge level can be queried at any time. 1) With the prosthesis switched on, press the charging receptacle button and hold for less than one second.
- Page 21 Event Cause Required action Unexpected prosthesis rectly configured in the • Adjust the values in the app under behaviour in case of differ app. "Settings > Advanced Settings" ent weight settings, e.g. when loading the prosthes is with excess weight Hand cannot be opened Faulty control •...
- Page 22 Bluetooth ID number 13.4 Directives and manufacturer’s declaration 13.4.1 Electromagnetic environment This product is designed for operation in the following electromagnetic environments: • Operation in a professional healthcare facility (e.g. hospital, etc.) • Operation in areas of home healthcare (e.g. use at home, use outdoors) Observe the safety notices in the section "Information on proximity to certain areas"...
- Page 23 Phenomenon EMC basic standard Interference immunity test level test procedure IEC 61000-4-11 Voltage drops 0% U ; 1 period 70% U ; 25/30 periods Single phase: at 0 degrees IEC 61000-4-11 Voltage interruptions 0% U ; 250/300 periods Interference resistance against wireless communication devices Test fre Frequency Radio ser...
- Page 24 The product is covered by the following patents: Patents pending in Germany and USA. Otto Bock Healthcare Products GmbH Brehmstraße 16 · 1110 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64 info.austria@ottobock.com · www.ottobock.com...